Bank Deposit Slips Templates

Company capabilities.

Able Electropolishing Co., Inc.

2001 S. Kilbourn Avenue

Chicago, IL 60623

Phone: 773-277-1600

Fax: 773-277-1655

E-mail: sales@ableep.com

Web: www.ableelectropolishing.com

VITAL STATISTICS

Year Founded: 1954

Number of Employees: 160

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

Able is America’s largest electropolishing specialist,
employing over 160 people on three shifts. The company operates a state
of the art facility in Chicago, IL. Literally thousands of companies
worldwide employ Able technology into their metal parts, with nearly
every industry utilizing the techniques developed and later refined by
our founder.

We are
ISO

 9001:2008 certified, ISO 13485 registered and our
process has been validated in accordance with “Quality Management
Systems–Process Validation Guidance” authored by SG3 and endorsed
by The
Global Harmonization task force

. Additionally, we are a certified
vendor for dozens of manufacturing companies in industries from
Aerospace to Medical and Semiconductor.

MAJOR MARKETS

Our process is widely used in the medical, dental, pharmaceutical,
aerospace, automotive, electronics, semiconductor and appliance
industries.

SERVICES OFFERED

[ILLUSTRATION OMITTED]

Electropolishing: Our proprietary reverse plating technique offers
solutions to a wide variety of metal surface problems. Brighten, deburr,
size and
passivate
  
v. pas·si·vat·ed, pas·si·vat·ing, pas·si·vates

v.tr.
1. To treat or coat (a metal) in order to reduce the chemical reactivity of its surface.

2.
 your parts all in one operation.

Passivation

: An acid cleaning process designed to remove free iron
from the surface of corrosion resistant steels. ABLE passivates per the

ASTM

abbr.
American Society for Testing and Materials
 A967 specification, as well as many other industry and
customer-specific standards.

Contract Cleaning: Able provides contract cleaning services on
metal parts from vapor degreasing to complex customer specific cleaning
specifications.

Titanium Electropolishing and Color Anodizing: Deburr, passivate,
and improve surface finish on your parts while providing easy
identification.

[ILLUSTRATION OMITTED]

www.ableelectropolishing.com

[ILLUSTRATION OMITTED]

Accellent

100
Fordham Road

 

Wilmington, MA 01887

Phone: 866-899-1392

Fax: 978-657-0878

E-mail: info@accellent.com

Web: www.accellent.com

VITAL STATISTICS

Year Founded: 2004

Number of Employees: 3000

Number of Facilities: Accellent is headquartered in Wilmington, MA
and has manufacturing facilities throughout the
United States
 officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world’s third largest country in population and the fourth largest country in area.
, Mexico,
Europe and Malaysia.

WHO WE ARE

Through deep expertise, Accellent provides expedient, high quality
and cost effective product solutions for our medical device customers in
the Cardio & Vascular, and Advanced Surgical markets. Product
solutions that give our customers a competitive advantage, delivering
innovative technologies and improving clinical outcomes for the patients
who need them most.

MAJOR MARKETS

Accellent’s comprehensive and diverse manufacturing
capabilities are now focused on the cardiovascular and advanced surgical
markets as follows;

Cardio & Vascular:

Catheters

* Microcatheters

* Steerable delivery catheters

* Braid-reinforced catheter shafts

* Electrophysiology ablation catheters–components and assemblies

Vascular Access
 Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing
 & Implants

* Wire based nitinol stents

* Tube based nitinol stents

* Precision interventional cardio guidewires

* Stylets

CRM

 & Neuromodulation Products

* Distal and proximal lead components and assemblies

* Lead body products

* Header block assemblies

Advanced Surgical:

Minimally Invasive Surgery
 Laparoscopic surgery, see there. See Laparoscopic cholecystectomy.
 

* Endomechanical/laparoscopic device components and assemblies

* Energy based device components and assemblies

*
Endoscopic
  
n.
An instrument for examining visually the interior of a bodily canal or a hollow organ such as the colon, bladder, or stomach.


en
 imaging device components and assemblies

Surgical Devices & Diagnostics

* Arthroscopic shavers and burrs

*
Breast biopsy
 Definition

A breast biopsy is removal of breast tissue for examination by a pathologist. This can be accomplished surgically, or by withdrawing tissue through a needle.
 needles (includes vacuum assisted)

* Orthopaedic large joint reconstruction instrumentation

* Orthopaedic bone screws

SERVICES OFFERED

Accellent offers a comprehensive medical device and component
product offering, from concept design input to complete supply chain
solutions.

Product Design & Development

* A structured design process

* Concept design–design verification–process validation-pilot
manufacturing

* Dedicated prototyping and cleanroom assembly

* Dedicated catheter development center

* FDA compliant

Precision Component
Fabrication
,
n the construction or making of a restoration.
 

* Metal tubing drawing

* Tube fabrication

* Machining

* Wire fabrication

* Medical component sub assemblies

* Injection molding/over molding

* Polymer tube extrusion

* Precious metal wire and tube fabrication

* Nitinol wire and tube fabrication

Medical Device Assembly

* FDA registered

* Cleanroom (class 8) assembly

* Class I, II and III device assembly

* Packaging, labelling and
sterilization

 

* Warehousing and distribution

www.accellent.com

Advanced Polymers, A Vention Medical Co.

29 Northwestern Drive

Salem, NH 03079

Phone: 603-327-0600

Fax: 603-327-0601

E-mail: info.ap@ventionmedical.com

Web: www.ventionmedical.com

VITAL STATISTICS

Year Founded: 1989

Number of Employees: 150

Number of Facilities: 1-60,000 sq. ft. state-of-the-art
manufacturing and R&D facility, ISO 13485:2003 registered

WHO WE ARE

[ILLUSTRATION OMITTED]

Advanced Polymers has been designing, developing, and manufacturing
unique and innovative polymer products for the medical device industry
for over 24 years. Our expertise in ultra-thin wall heat shrink tubing
and medical balloon manufacturing has earned us an excellent reputation
throughout the medical device industry. As part of Vention Medical, we
are now able to offer our customers a much broader range of products and
services including finished balloon catheters. We also design, develop
and manufacture multi-layer, co-extruded and
braided
  
adj.
1.
a. Produced by or as if by braiding.

b. Having braids.

2. Decorated with braid.

3.
 tubing.

MAJOR MARKETS

We are dedicated 100% to the medical device industry.

SERVICES OFFERED

Advanced Polymers is well-known throughout the medical device
industry for developing innovative polymer products and technologies,
including the world’s thinnest, smallest and strongest heat shrink
tubing and complex compliant, semi-compliant and noncompliant medical
balloons. With a commitment to consistent quality, API provides
outstanding products to customers who utilize our components in the
manufacture of minimally invasive devices, procedures, and leading-edge
medical technology. Advanced Polymers is capable of both high and low
volume manufacturing. No job is considered too small or too large. API
custom manufactures medical balloons in Polyurethane, Nylon, PET and
other proprietary polymers.

[ILLUSTRATION OMITTED]

Visit our new on-line catalogs to order stock heat shrink tubing,
medical balloons and multi-layer tubing. Customers can order 24/7 using
a credit card, and most orders ship within 48 hours. API stocks over 500
sizes of heat shrink tubing and over 90 medical balloons in
Polyurethane, Nylon and PET.

Vention Medical’s areas of expertise include:

* Product Design and Development

–Interventional and minimally invasive surgical devices

* Advanced Components

–Heat Shrink tubing

–Medical balloons

–Single and multi-lumen tubing

–Multi-layer tubing

–Co-extruded tubing

–Braided tubing

* Contract Manufacturing

–Injection/Insert/Micro/Two shot molding

–Complete device assembly and packaging

–Supply chain management

–Sterile barrier packaging design and development

–Sterilization management

www.ventionmedical.com

[ILLUSTRATION OMITTED]

ASI

n See Anxiety Sensitivity Index.
 

163 Research Lane

Millersburg, PA 17061

Phone: 800-724-4158

Fax: 717-692-2197

E-mail: sales@asisus.com

Web: www.asisus.com

VITAL STATISTICS

Year Founded: 1987

Number of Employees: 300

Number of Facilities: 2

WHO WE ARE

Medical OEMs have trusted ASI for over twenty-five years to design
and manufacture solutions for the medical device, diagnostic and drug
delivery markets. The company partners with its customers to develop
solutions, which are safe, innovative and cost competitive. ASI’s
success comes from its experience to integrate design and manufacturing
to deliver low cost, high quality solutions.

MAJOR MARKETS

Medical Device, Pharmaceutical, Biotechnology, Diagnostic and Drug
Delivery.

SERVICES OFFERED

[ILLUSTRATION OMITTED]

Fluid Management

Single-Use fluid management systems are used in a wide range of
applications within patient-care specialties. ASI’s flexibility
results in the best combination of materials, characteristics and
designs for our customer’s applications. Bags can be made from
Polyethylene (PE), Polypropylene (PP),
Ethyl
 , CH3CH2, organic free radical or alkyl group derived from ethane by removing one hydrogen atom.
 
Vinyl Acetate

 (EVA), Poly

Vinyl Chloride

 (
PVC
 see polyvinyl chloride.


PVC
 in full polyvinyl chloride

Synthetic resin, an organic polymer made by treating vinyl chloride monomers with a peroxide.
),
Fluorinated Ethylene Propylene

 (
FEP

) or Foil
medical grade films. Standard and custom configurations are available
ranging from 50 ml 2-Dimensional bags to 3,500 L 3-Dimensional bags.
Side or face ports can also be selected per the application.

[ILLUSTRATION OMITTED]

Precision
Injection Molding

n.
A manufacturing process for forming objects, as of plastic or metal, by heating the molding material to a fluid state and injecting it into a mold.
 

ASI’s injection molding machines operate in an ISO Class 8
clean room staffed with technicians who are specially trained in
Scientific Molding and equipped with state-of-the-art, high speed,
robotic presses. Capabilities include: injection molding, over-molding,
multi-shot molding, plus a variety of secondary operations that include:

ultrasonic welding

,
resistance welding

A process in which the heat for producing the weld is generated by the resistance to the flow of current through the parts to be joined.
, robotic gluding and
laser
engraving

. ASI also offers product prototyping, tool design and
fabrication and automated component assembly.

[ILLUSTRATION OMITTED]

Product and Supply-Chain Management

Experienced Engineers and Program Managers will evaluate your
product and develop improvements that create
sustainable value

 for your
customers and your company. The scope of our evaluation process includes
quick process improvements, long-term redesigns, supply-chain
optimization and product life-cycle management.

[ILLUSTRATION OMITTED]

New Solutions for Mature Products

What makes ASI a successful mature program outsourcing partner
comes from our ability to bring new solutions to mature products.
Customers choose ASI to optimize mature products that require additional
manufacturing space, new innovations or additional margin.

www.asisus.com

[ILLUSTRATION OMITTED]

Aspect Automation

677 Transfer Road

St Paul, MN 55114

Phone: 651-643-3700

Fax: 651-642-5665

E-mail: sales@aspectautomation.com

Web: www.aspectautomation.com

VITAL STATISTICS

Year Founded: 2008 (as Aspect Automation)

Number of Employees: 67

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

Aspect Automation designs and builds custom automation equipment.
We have the reputation of streamlining complicated processes and our
clients look to us as the experts in understanding what it takes to
automate their processes. Our engineering expertise and equipment
reliability are unrivaled. We’ve spent 60+ years honing our skills
and knowledge to develop processes, resources, and technologies
resulting in innovative solutions that make us an industry leader in
equipment performance and client satisfaction.

Aspect Automation is ISO 9001:2008 certified and utilizes the
following medical validation compliant methodology: 21
CFR

 Part 11,
Parts 210 and 211, cGMP, GAMP, CE and UL.

MAJOR MARKETS

Our diversification and experience across platforms and markets has
deepened our insight and enriched our problem-solving expertise. We
service the following markets:

Medical–Medical Devices, In Vitro Diagnostics, Drug Delivery,
Laboratory Diagnostics, Dental, Energy Storage

Industrial–Adhesives, Abrasives, Filtration

Consumer–Filtration, Adhesives, Display Glass, Window Frames and
Components, Doors, Frame and Components

SERVICES OFFERED

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

We deliver superior results, which has attracted our client list of
numerous Fortune 500 companies. Aspect Automation is in the business of
helping clients succeed by diagnosing their manufacturing problems and
developing solutions that meet all their requirements.

Our services, technologies, and capabilities include:

* Coating Technology

* Complex Control Systems

* Concept Development

* Data Collection & Management

* Medical Device Assembly

* Medical Validation/GAMP Compliant

* Process Development/DFM/DFA/PoC

* Robotic Applications

* Vision Systems

* Web Processing

* Additional areas we excel in: Die Cutting, Filling, Fluid
Delivery, Heat Sealing, Integration, Project Management

www.aspectautomation.com

[ILLUSTRATION OMITTED]

ATL

 Technology, LC

1335 West 1650 North

Springville, UT 84663

Phone: 801-489-9100

Fax: 801-491-6364

E-mail: sales@atlconnect.com

Web: atltechnology.com

VITAL STATISTICS

Year Founded: 1993

Number of Employees: 450

Number of Facilities: 3

WHO WE ARE

ATL Technology, LC is a USA based engineering company that owns a
manufacturing facility in Dongguan China. We specialize in Disposable
Medical Cables, Custom Medical Cables, Custom interconnects assemblies,

Pad Printing

, Over-Molding and Turn-Key manufacturing solutions. Our
wholly-owned Dongguan, China Facility is designed to operate
according
to


prep.
1. As stated or indicated by; on the authority of:

2. In keeping with:

3.
 the demanding specifications of ISO 13485, ISO 9001, ISO 14001, for
the medical and
OEM

 industries.

MAJOR MARKETS

We supply customers worldwide with high quality, cost effective,
engineered solutions. Our combination of engineering support, guaranteed
quality, and just-in-time warehousing makes us an ideal fit for Medical
companies, and OEMs.

CAPABILITIES

Disposable Electrosurgical Assembled: ATL has global design,
manufacturing and support capabilities from strategic locations in the
USA, Taiwan and China. We build hundreds of thousands of ablation
equipment cables and devices. This means we have a sound understanding
of thermocouple wire termination. We use two-conductor pairings of
ChromeI-Alumel, Copper-Constantan wire.

Catheter and Interface Cables: ATL designs and manufactures
catheter cable assemblies. We offer multi-material construction and
reinforced wire or braided material for superior resistance to kinking.
Our primary catheter materials are polyurethane and polyethylene;
however, we have experience in working with a wide range of other
catheter materials. We offer adhesive or UV curing for tube bonding,
integration with embedded PCBs or sensors, plus complete assembly and
pack-out services.

[ILLUSTRATION OMITTED]

Catheter Interface Cable Assembles: We also build catheter
interface cables terminated with OEM branded connectors from Lemo,
ODU

ODU Optical Channel Data Unit
ODU Operational Dress Uniform
ODU Optical Density Unit
ODU Optical Demultiplexing Unit
ODU Outdoor Device Unit
 or Fischer or we will manufacture a Lemo equivalent connector to save
significant cost.

Coextrusion: Surgeons often comment how crowded the
operating room

n. Abbr. OR
A room equipped for performing surgical operations.
 is becoming with cables and devices strung throughout the OR. ATL offers
the solution for your end customer by Co-Extruding cable and lumen
reducing the number of individual cords and tubes. Co-Extrusion cables
can carry saline, air and electrical signals side by side. Wire with
single lumen or multi-lumen will simplify your design and provide you
with tremendous advantages when selling your solutions into the medical
market.

Monitoring Cables: ATL Manufactures high quality, build-to-print
patient monitoring cables like
EKG
 see electrocardiography.
,
ECG
 electrocardiogram.


abbr.
1. electrocardiogram

2. electrocardiograph


Also called an electrocardiogram, it records the electrical activity of the heart.
, and
EEG
 see electroencephalography.
, our over-molding
capabilities allow us to fully
encapsulate

v.
1. To form a capsule or sheath around.

2. To become encapsulated.


en·cap
 connectors and provide
flexible strain reliefs that actually protect the cable. Overmolds can
be in a variety of colors allowing for easy lead identification. PCBs
can be added in the yoke to produce smart cables.

Patient Care: Cables,
stretchy
  
adj. stretch·i·er, stretch·i·est
1. Capable of being stretched:

2. Tending to stretch excessively.

Adj. 1.
 cables, and lead wires,
ECG/MRI/Network cables and Power cords.

Custom Connectors: ATL Technology designs complete connector
systems to meet the demanding usage requirements found in medical and
OEM environments. Our engineering group can design disposal circular
connectors for medical devices, or custom connector systems designed to
meet your specific needs. The connectors can be designed for
SMT

,
thru-hole, or connector to wire applications. With ATL you get in-depth
connector design experience, international quality standards,
competitive pricing, and
rapid prototyping

 with the ability to drop-ship
anywhere in the world.

Connector Options: Any engineered plastic, brass, copper, copper
alloys, steel substrates with nickel, tin, or
gold plating

, Solder
tails, SMT, Solder cup,
crimp

, or IDC concepts,
Hermaphroditic
  
n.
1. An animal or plant exhibiting hermaphroditism.

2. Something that is a combination of disparate or contradictory elements.
 designs
or custom keying options, High normal force mating and high
insertion/extraction requirements.

atltechnology.com

Aubrey Group, Inc.

6 Cromwell, Suite 100

Irvine, CA 92618

Phone: 949-581-0188

Fax: 949-581-0177

E-mail: info@aubreygroup.com

Web: www.aubreygroup.com

VITAL STATISTICS

Year Founded: 1994

Number of Employees: 50

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

We are an engineering, product development, and contract
manufacturing company specializing in the design of complex
electro-mechanical devices and disposables. We collaborate with clients
to develop products that work reliably and meet regulatory and industry
standards. We are committed to designs of the highest quality, lives
depend on it.

MAJOR MARKETS

Our technical skills and experience have been used in wide-ranging
surgical, diagnostics, patient monitoring, and therapeutic products and
applications. Sectors include cardiovascular, ophthalmology,
orthopedics,
gastroenterology

,
urology

, gynecology, dermatology, and
aesthetics. Our core technologies include:

* Microfluidics

* Pump Technologies

*
GUI

 

* Electrochemistry

* Wireless Devices

* RF Generators

* Embedded Controls

*
Bioelectronics

A discipline in which biotechnology and electronics are joined in at least three areas of research and development: biosensors, molecular electronics, and neuronal interfaces.
 

* Disposables

SERVICES OFFERED

Our services and capabilities are broad and deep and span over the
full product lifecycle, from concept definition, product development,

verification and validation

 to contract manufacturing and sustaining
engineering. We partner with you to meet the requirements of the FDA,

FCC

,
ICC

, and UL. We are UL registered, ISO 13485 and ISO 9001:2008
certified and an FDA-registered medical device manufacturer.

Product Development

Aubrey Group has an experienced engineering team that has developed
fast-tracked projects, met milestones, and produced working prototypes
successfully. We work well together and know the medical device design
landscape, regulatory and safety issues, and systems integration. We
have developed reliable partners to work with. Our approach has proven
very successful in our fast paced environment.

Regulatory Compliance and Quality

Compliance to regulatory standards is a large and very important
part of medical device development. Aubrey Group’s Regulatory and
Quality Department can guide new products through the regulatory
process, evaluate existing devices and perform gap analyses to
standards. We offer a cost-effective and proven process to both manage
and mitigate the risks associated with compliance to regulatory
standards.

Project Management

Our management philosophy encourages a collaborative environment
and we balance productivity and budget milestones with engineering
creativity. Our project managers provide our clients with weekly
progress reports to budget and schedule, and clients have remote, secure
access to their project files. Emphasis is placed on client
communication with contact across all functional levels of the
client’s team.

Contract Manufacturing

Our focus is on quality, service, and flexibility. Aubrey Group
provides integrated, turnkey solutions using leading-edge manufacturing
technologies. By optimizing modularity of design, practicality in
product manufacturability, and reliable repair, our experienced
manufacturing team sets a high standard for the ability to respond to
customer requirements. We continue our role as fullservice partner after
design and manufacturing by offering distribution, warranty repair,
service, and end-of-life management services. We support manufacturing
transfer from outside design firms as well as our internal design and
development team.

www.aubreygroup.com

Autocam Medical

Kentwood, MI USA Plymouth, MA USA Hayward, CA USA

616-541-8080 508-830-1442 510-487-7600

Toll Free: 877-633-8080

E-mail: contact@autocam-medical.com

Web: www.autocam-medical.com

Sao Joao da Boa Vista, Sao Paulo, Brazil

+ 55-19-3206-2123

VITAL STATISTICS

Autocam Corporation/Autocam Medical

Year Founded: 1988

Number of Employees: 1,500

Number of Facilities: 12 on 4 continents

Certifications: ISO 9001:2008/ISO 13485:2003; FDA Registered

WHO WE ARE

Autocam Medical is a contract manufacturer of highly engineered
parts for demanding medical applications. We have decades of expertise
in every aspect of high-precision manufacturing, with specialties in
CNC

 milling, turning and grinding of surgical-grade materials. World-class
manufacturing quality, combined with solid expertise in gauging and
secondary finishing processes, means Autocam Medical can consistently
deliver a better-performing product.

MAJOR MARKETS

Primary Markets: Orthopedic (Trauma, Reconstructive, Sports

Medicine, Arthroscopic) Spine, Cardiovascular/Vascular,

Minimally-lnvasive, Dental and Ophthalmic

Implants: Complex bone plates, and other fixation devices; bone
screws; hips (heads, shells); shoulders and extremity components.

Instruments/Handpieces: Drill bits, drill guides, screw drivers,
taps, cutting tools and components for ultrasonic handpieces.

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

SERVICES OFFERED

State-of-the-art equipment (Matsura, Citizen, Chiron, Zeis);
customized tool forming and highly skilled workers add value to the
entire manufacturing process–from First Article parts to late-stage
contracts.

CNC Precision Turning: CNC Fixed, CNC Swiss, Ultra-precision

CNC Precision Milling: 3rd, 4th, 5th Axis, Horizontal, Vertical

CNC Precision Mill/Turn

CNC Precision Cutter Grinding: Single-Axis, Multi-Axis

CNC Precision Grinding: Surface, Cylindrical, Centerless

Laser: Machining, Cutting, Etching, Marking, Welding

Deep-Hole Gun-Drilling

Finishing: Bead Blast, Electropolish, Passivation, TiN Coat, Hone,

Extrude
 /ex·trude/ ()
1. to force out, or to occupy a position distal to that normally occupied.

2. in dentistry, to occupy a position occlusal to that normally occupied.
 Hone, Spherical Lapp

Precision Cleaning, Subassembly, and Non-Sterile Packaging

Materials: All Medical grades of
stainless steel
 see steel.


stainless steel

Any of a family of alloy steels usually containing 10–30% chromium. The presence of chromium, together with low carbon content, gives remarkable resistance to corrosion and heat.
, titanium, cobalt
chrome
moly

 (CCM/CCM+), nitinol (NiTi), exotic alloys, aluminum, brass
and polymers, including PEEK and polyethylene (
UHMWPE

).

www.autocam-medical.com

[ILLUSTRATION OMITTED]

Aztalan Engineering, Inc.

100 S. Industrial Drive, P.O. Box 739

Lake Mills

, WI 53551

Phone: 920-648-3411

Fax: 920-648-8066

E-mail: info@aztalan.com

Web: www.aztalan.com

VITAL STATISTICS

Year Founded: 1978

Number of Employees: 66

Number of Facilities: 2

WHO WE ARE

Aztalan Engineering is a manufacturer of “world class”
precision machined parts. Most of our parts are used in critical
applications where component failure is not an option. Regardless of the
application, your parts will receive the same attention to detail and
built-in quality that our most critical customers demand. From process
control to metrology to design for manufacturing our Mechanical
Engineers and highly trained production staff will solve your problems
and bring your products to life. With certifications to ISO 9001, ISO
13485, and AS 9100 we are not only accountable to established standards
of quality and improvement but incorporate them throughout our
organization. We will provide your company with transparent pricing,
short lead-times, the highest quality, supply chain management, and
“best in industry” customer service.

MAJOR MARKETS

Diagnostic, Imaging, Cardiology, Ophthalmology, Oncology Therapy,
Anesthesia Management, Infant Care, Drug Delivery,
Surgical Instruments

,

Neurosurgery
 /neu·ro·sur·gery/ () surgery of the nervous system.


n.
Surgery on any part of the nervous system.
, Respiratory Care, Orthopedic, Dental and Veterinary.

SERVICES OFFERED

Aztalan Engineering is your single-source for precision machining
and assemblies. We take great pride in solving complex problems
associated with the design and manufacturing of precision machined
parts, and have over 30 years of experience and success working with
clients all around the world.

You begin to understand our commitment to excellence with your
first contact with us. When you tour our facility you will notice this
commitment entrenched throughout our organization. Building 1 is a
30,000 square foot manufacturing facility, and is host to our CNC Single

Spindle Turning

, CNC Swiss Turning, Customer Specific Cells and Solder
and Brazing operations. We completed construction on Building 2, a
46,500 square foot facility that hosts our CNC Milling, 5-Axis Milling,
and CNC Twin Spindle Turning Operations, in january of 2011. Both
facilities use state-of-the-art technology from receiving of raw
material through the shipment of our finished products.

What you’ll see:

* Controlled flow of material and work-in-process

* Process validations

* Use of automation and robotics

* Efficient work stations

* Immaculate cleanliness

* Environmentally-controlled production and inspection areas

* Class 10,000 capable clean room assembly

* Highly skilled and motivated employees

Engineering

Aztalan Engineering has full design and manufacturing engineering
capabilities to support your product launch and revisions. By working
directly with your engineers through every stage of product development,
we also build a bond and intimate level of product knowledge that can be
carried into production manufacturing. We use SolidWorks, AutoCAD,
Boothroyd Dewhurst
DFMA

 and
CAD/CAM

 software to support your projects
and share information.

Secondary Operations

At Aztalan Engineering we take great pride in our qualification and
management of our service suppliers. We have a qualified supply chain to
cover almost every operation your product may require.

www.aztalan.com

[ILLUSTRATION OMITTED]

B. Braun OEM Division

824 12th Avenue

Bethlehem, PA 18018

Phone: Toll-free 866-8-BBRAUN; 610-691-6785

Fax: 610-691-1785

E-mail: contact-usa@bbraunoem.com

Web: www.bbraunoem.com

VITAL STATISTICS

Year Founded: 1957

Number of Employees: 42,000

Number of Facilities: 26

WHO WE ARE

The B. Braun OEM Division of B. Braun Medical Inc. delivers
complete contract manufacturing capabilities for a multitude of markets
including surgical, pharmaceutical and biotech. With three global
divisions (Europe, Asia-Pacific and
North America
 third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere.
), B. Braun OEM
Division offers wide-ranging and complementary capabilities resulting in
new products, expanded production, cost efficiencies, and
country-specific knowledge.

Facilities

Part of a newark of 26 global production facilities, our primary
400,000-square-foot U.S. plant includes a 16,500-square-foot ISO Class 8
molding facility. It houses some of B. Braun’s 80 injection molding
presses, which range from 55 to 330 tons. The B. Braun OEM Division has
the in-house capabilities, project management approach and
lean
manufacturing

 practices to take your designs from concept to delivery.

Company Statistics

B. Braun’s renowned manufacturing and engineering resources
have been cultivated through 176 years in the medical device business
and more than 50 years serving OEM customers. Through our Sharing
Expertise initiative, customers have immediate access to our resources.

MAJOR MARKETS

Pharmaceutical, Biotech, Interventional, Laparoscopic,
Arthroscopic, Endoscopic, Urologic, Cardiovascular, Ophthalmic and

Women’s Health
 Definition

Women’s health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 

SERVICES OFFERED

Products

We build an extensive range of devices, kits and components to meet
a variety of needs. Our manufacturing facilities are flexible enough to
produce everything from customized products requiring manual assembly to
high-volume quantities. With extensive in-house production capabilities,
B. Braun can manufacture fluid administration and management sets,
valves, catheters, interventional products and admixture products in
varying sizes and materials.

Recent Developments

With 34,000 square feet of custom product manufacturing space and a
16,000-square-foot ISO class 8 cleanroom for injection molding, a recent
addition to B. Broun’s Allentown, PA facilities expands the
company’s capacity to meet the growing demand for contract
manufacturing services. Optimized for flexibility, the manufacturing
space was designed to accommodate low-volume, manual and semi-automated
device assembly and production.

Services

B. Braun OEM Division offers an integrated range of services to
expedite time to market. Available services include research and
development, laboratory, design, prototyping, tooling, molding,
extrusion, validation, manufacturing, packaging, kitting, private
labeling, sterilization, quality control and regulatory guidance and
select supply chain management services.

www.bbraunoem.com

[ILLUSTRATION OMITTED]

Benlan, Inc.

2760 Brighton Road

Oakville, Ontario L6H 5T4

Phone: 905-829-5004

Fax: 905-829-5006

E-mail: sales@benlan.com

Web: www.benlan.com

VITAL STATISTICS

Year Founded: 1978

Number of Employees: 250+

Number of Facilities: 1

Annual Sales: Proprietary

WHO WE ARE

[ILLUSTRATION OMITTED]

Established in 1978 as a supplier of medical grade tubing and
molded components to the healthcare markets both in
Canada and the
United States

, Benlan soon experienced rapid growth in the number of
product offered and customers serviced throughout the world.

Benlan’s state-of-the-art 50,000 sq. ft. facility is located
in Oakville (30 minutes west of Toronto, Canada) which is strategically
located near the Buffalo, NY entry port to seamlessly service the US
customers.

Benlan, Inc. has received the ISO 9001:2008 and ISO 13485:2003
certification and is an FDA registered facility. The ISO certification
meets the new
Health Canada

 regulations for medical device manufactures
that were implemented July 1st 2001.

MAJOR MARKETS

OEM Medical device and related component to the Canadian, US and
world markets.

SERVICES OFFERED

Benlan offers a wide range of contract manufacturing services
including:

* Component parts–extruded, injection molded and assembled

* Medical Devices–finished assemblies both bulk non-sterile and
packaged sterile

* Kit packaging, bagging, and various form-fill-and-seal operations

* Private label and special packaging options with high resolution
printing capabilities

* Engineering and design services as well as support in regulatory
compliance and sterilization validations

Medical tubing extrusion is one of the core competencies of the
company. We are currently processing but not limited to:
HDPE

abbr.
high-density polyethylene
,
MDPE

MDPE Mobile Dual-Phase Extraction
MDPE Maximum Permissible Dose Equivalent
,

LDPE

abbr.
low-density polyethylene
, EVA, Polypropylene, C-Flex [a non-vinyl option], FPVC,
RPVC

,
TPO

,

TPR
 1 Temperature, pulse, respiration 2 Third-party reimbursement, see there 3. Total pulmonary resistance
 and TPE’s. Compliments to the extrusion include:

* In-line angle cut tubing

* Coiling/Banded

* Custom Colors/Tints

* Eyed and Tipped Tubing Ends

* Punching/Skiving

* Solvent Bonding

* UV-Cure Gluing

* Cynoacralate Gluing

* Striped Tubing/Radio Opaque Striped/Ribbed/Tinted

* Thermo Formed FPVC Coils/Coil Lines

* High Resolution Printed Tubing

Benlan provides a number of injection molded components; filters,
connectors, luers, Y-connectors, high pressure rated single and dual
check valves and Yankauers to name a few for the OEM market. Our molding
group offers fully integrated support for component design, material
selection, mold manufacturing and component production to meet your
specific requirements.

We will work closely with you to develop a package of services
tailored to your unique requirements, including manufacturing, assembly,
packaging and sterilization. Currently Benlan, Inc. manufactures
finished assemblies/products in the following categories:

* Anesthesia Kits and Trays

* Contrast Management

* Custom Kits including IV,
Suture
 /su·ture/ ()
1. sutura.

2. a stitch or series of stitches made to secure apposition of the edges of a surgical or traumatic wound.

3. to apply such stitches.

4.
 Removal, etc.

* Dialysis Trays

*
Enteral
 /en·ter·al/ () enteric.


adj.
1. Within or by way of the intestine, as distinguished from parenteral.

2. Enteric.
 Feeding for both Adult and Neo-Natal Application with
Enteral Safe Tips

* Huber Needles (standard and safety versions)

*
Insufflation
 /in·suf·fla·tion/ ()
1. the act of blowing a powder, vapor, or gas into a body cavity.

2. finely powdered or liquid drugs carried into the respiratory passages by such devices as aerosols.
 Filters and Sets

* Respiratory including oxygen tubes and various suction devices

* Urology including Cysto and
TUR
 see ibex.
 Sets,
Foley Catheter

n.
A catheter held in the bladder by an inflatable balloon.


A two-channel catheter with a balloon on the bladder end of one channel.
 and

Irrigation
 in agriculture, artificial watering of the land. Although used chiefly in regions with annual rainfall of less than 20 in. (51 cm), it is also used in wetter areas to grow certain crops, e.g., rice.
 Trays, etc.

* Yankauers (Bulb and Regular Tip/Vented and Non-Vented)

www.benlan.com

Bonifacio Consulting Services,
LLC

 

Natick, MA 01760

Phone: 310-683-3257

E-mail: info@bonifacioconsulting.com

Web: www.bonifacioconsulting.com

VITAL STATISTICS

Year Founded: 2007

Number of Employees: 5

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

Bonifacio Consulting Services (
BCS

) is a Global Medical Device
Manufacturing Advisory firm. We are experts in the precision
manufacturing of medical device components, assemblies, disposables and
consumables.

BCS Advisors come from an extensive Operating Perspective in the
medical device manufacturing industry. Our Principal, Mark Bonifacio has
over 25 years of experience in medical device manufacturing working for
OEMs and various Contract Manufacturers. His experience also includes
co-founding and selling APEC, a successful and profitable Medical Device
Contract Manufacturer located in southern California, to Helix Medical.
All BCS Advisors have been in leadership positions in large and small
Medical Device
manufacturing operations

.

BCS is committed to leveraging our backgrounds and extensive
network to maximize the success of our clients whether through
operational improvement, business development or through superior
acquisition and integration execution.

BCS approaches every client engagement as a strategic partnership.
Our goal is a
mutually beneficial

 and long-lasting relationship where we
are an important contributor in achieving maximum enterprise value and
long term competitive advantage.

MAJOR MARKETS

Small and Large Medical Device Contract Mfg’s, Medical and
Surgical Devices and Products: Catheters, IV’s, Respiratory,
Anesthesia, Medical Injection Molders, Medical Extrusion, Minimally
Invasive Surgical,
Investment Banks

, Private Equity’, Medical
Device OEM’s.

SERVICES OFFERED

BCS advisors are focused and responsive to your needs providing
timely, actionable advice/solutions with extensive medical device
manufacturing & medical plastics expertise (by a highly experienced
team; all with significant operational experience).

BCS offers services globally and our team is ready to provide you
with the support, knowledge and expert advice based on your needs of
development.

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

Capabilities:

* Exit Planning/Post Merger Integration

* M&A Buy/Sell; Divestitures

* Technical & Business Advisory

* Executive Recruitment

* Business/Marketing Opportunity Assessment & Research

* Joint Ventures, Licensing

* Board Advisory

*
Executive Coaching

 

www.bonifacioconsulting.com

[ILLUSTRATION OMITTED]

Boyd Coatings Research, Inc.

51 Parmenter Road

Hudson, MA 01749

Phone: 800-258-0110 or 978-562-7561

Fax: 978-562-9622

E-mail: info@boydcoatings.com

Web: www.boydcoatings.com

VITAL STATISTICS

Year Founded: 1965

Number of Employees: 100

Number of Facilities: 1

Certifications: ISO 9001:2008 Certified, FDA Compliance

WHO WE ARE

[ILLUSTRATION OMITTED]

Boyd Coatings creates and applies high-performance coatings to meet
clients’ specific medical device needs. Boyd Coatings is ISO
9001:2008 certified, has been in business for over 47 years and has the
capability to apply any brand or type of coating.

MAJOR MARKETS

Markets of primary interest for Boyd include:

* Medical Device Coatings, which can increase functionality,
versatility and ease of use

* Industrial Coatings, which affect wear resistance, corrosion, and
friction and can impart non-stick characteristics

* Aerospace Coatings, which can provide protection against high
temperatures, high pressure, moisture, chemical attack, abrasion and
other extreme conditions

SERVICES OFFERED

From its state-of-the-art, ISO 9001:2008 facility, Boyd Coatings
applies high performance coatings to meet clients’ specific medical
device needs in full compliance with FDA regulations. Boyd Coatings also
can create and/or manufacture custom coatings for performance
characteristics not currently available elsewhere. Able to process a
wide variety of materials as well as shapes and sizes, Boyd has both
manual spray capability for small quantities and automated robots for
larger volumes. Boyd is a licensed
applicator

n.
An instrument for applying something, such as a medication.


n a device for applying medication; usually a slender rod of glass or wood, used with a pledget of cotton on the end.
 of advanced technologies
such as Dupont Teflon[R] and Whitford Worldwide
Xylan
 /xy·lan/ () any of a group of pentosans composed of xylose residues; major structural constituents of wood, straw, and bran.
[R]. Our high
volume, flexible manufacturing capabilities allow us to coat both small
quantities and larger weekly releases, quickly and cost-effectively.
From project definition and design, including on-site consulting and
custom color matching, all the way to delivery, Boyd continually works
to ensure customer satisfaction.

[ILLUSTRATION OMITTED]

Specializing in coatings for:

*
PTFE

 Custom-Coated Guidewires

* Surgical Instruments

* Assay and Diagnostic Equipment

* MIS Devices

* Dental Appliances

* and more

Contact us today to discuss where we can help start your project
with a finish.

www.boydcoatings.com

[ILLUSTRATION OMITTED]

Bradshaw Medical, Inc.

10325 58th Place–Kenosha, Wl 53144

PH: (877) 201-7661

FX: (262) 925-1380

www.bradshaw-medical.com

Vital Statistics

Year Founded: 2006

Number of Employees: 100+

Number of Facilities: 1

Annual Sales: $25M+

Who We Are

Bradshaw Medical (
BMI
 body mass index.


abbr.
body mass index


A measurement that has replaced weight as the preferred determinant of obesity.
) gives you the competitive edge in
today’s highly specialized design and development of OEM orthopedic
and spinal instruments. We manufacture world class instruments to meet
your most demanding requirements. Our team is ready to work closely with
your staff in providing solutions to the challenges of today’s
highly competitive marketplace. We have the Experience, Vision, and
State of the Art R&D manufacturing capabilities to be able to
develop innovative instruments in time for your next critical product
launch.

Quality: our goal is that our business decisions portray
durability, trustworthiness, longevity, superiority and accountability.

Innovation: We strive to achieve the extraordinary with our
produces and services through the continuous improvement you would
expect from a market leader.

Service: We mare positive, lasting impressions by caring for OEMs,
individuals, doctors and nurses.

Services Offered

Custom Instrumentation Comfort Grip[TM] Silicone Handles Spine
Screw Extraction Systems
Spinal Instrumentation
 Definition

Spinal instrumentation is a method of straightening and stabilizing the spine after spinal fusion, by surgically attaching hooks, rods, and wire to the spine in a way that redistributes the stresses on the bones and
 Non-Ratcheting Drivers
Total Control[TM] Ratcheting Drivers Total Control[TM] Torque Limiting
Drivers Total Control[TM] Torque Limiting
Ratchet

 Drivers Bone Awls,
Probes and Sounders

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

Rule # 1: If we dont take care of our customers someone else will,

There resides a great pride within our company in providing you
with top notch orthopedic and spinal instrumentation. We invite you to
contact us at the earliest concept phase to ensure a seamless transition
from prototype through production. Our knowledgeable staff has over 25+
years of industry experience and is available at all developmental
stages to ensure you receive the support that you deserve. We genuinely
care about each and every customer and strive to respond to your
requests within 24-48 hours. We understand the importante in meeting
your critical launches and we are here to support all of your
requirements.

Branch Medical Group

200 Schell Lane

Phoenixville, PA 19460

Phone: 877-99BRANCH or 484-921-3000

Fax: 484-923-1072

E-mail: djones@branchmedicalgroup.com;

customerservice@branchmedicalgroup.com

Web: www.branchmedicalgroup.com

VITAL STATISTICS

Year Founded: 2005

Number of Employees: 90

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

Branch Medical Group is a world-class contract manufacturer for the
medical industry. We also design and manufacture sterilization
trays/graphic cases. We are a group of professionals with vast
experience in the technical, engineering, and business aspects of
manufacturing. We assemble and package parts in our Class 10,000 (ISO 7)
clean rooms for your sterile packaging needs. Work with us and you will
discover we make commitments and not mere promises. To us, it’s
more than just business; it’s the business of life.

MAJOR MARKETS

Orthopedic, Cardiovascular, Dental and Aerospace

SERVICES OFFERED

[ILLUSTRATION OMITTED]

We pursue cutting-edge technologies, so people can get a second
chance at life. You’ll find that commitment reflected in our
sprawling state of the art facility that houses world class machinery;
eight-axis mill turns, seven-axis swiss lathes, simultaneous five-axis
bar fed mills,
EDM

 Machines, dedicated machines for PEEK implants, and
cell based manufacturing systems for graphic cases. This defines us as
one of the premier contract manufacturers of machined components,
assemblies and sterilization trays.

We translate your specifications into a cutting-edge product
showcase of titanium, stainless steels, plastics, PEEK and a palette of
other high quality materials.

We can both design and manufacture instrument and implant trays,
modules and the cases in which they are housed. Durable medical grade
materials, sturdy brackets and solid stainless steel rivets–all come
together seamlessly in perfect detail. They are designed to create
harmony in form and function–from how cases are transported, stored at
hospitals to being prepared for surgery and cleaned/autoclaved after
surgery.

Branch takes great care of your product from beginning to the end.
Our state of the art clean rooms push the boundaries of clean.

* Multiple component assembling.

* 6 independent class 10k clean rooms

Branch is a team of professionals that work with you every step of
the way to create products with jewel-like precision. We are committed
to unraveling challenges and finding ways to get things done right. Our
team of experts can partner with your company across all
products–spinal, orthopaedic, cardiovascular and dental implants. But
it all begins by asking us questions. You’ll find the answers are
true to your vision.

www.branchmedicalgroup.com

C&J Industries

760 Water Street

Meadville, PA 16335

Phone: 814-724-4950

Fax: 814-724-4959

E-mail: sales@cjindustries.com

Web: www.cjindustries.com

VITAL STATISTICS

Year Founded: 1962

Number of Employees: 290

Number of Facilities: 1–200,000 sq. ft.

WHO WE ARE

[ILLUSTRATION OMITTED]

C&J Industries is an FDA registered manufacturer of medical
devices and plastic injection molded components. C&J is ISO
9OO1:2008 and ISO 13485:2003 certified with 50 years of experience. We
have the certifications, state-of-the-art equipment and capacity to
serve your medical device and pharmaceutical packaging needs.

MAJOR MARKETS

C&J Industries serves the following markets: Medical Device,
Pharmaceutical, Telecommunications, Industrial, Transportation, Consumer
Products and Business Machines.

With over 30 years of Medical Device manufacturing experience,
C&J Industries has both the talent and experience to bring your
product to market on time and in budget. C&J can help you with IQ,
OQ & PQ validation protocols for all phases of the product
fulfillment cycle. While servicing many of the leading Medical Device
and Pharmaceutical OEM’s, C&J understands what it takes to meet
the most stringent standards in the industry.

SERVICES OFFERED

C&J Industries is a complete source for all your Plastic
Medical Device and Pharmaceutical Packaging needs. C&J has been a
leader in the custom plastic injection molding business for 50 years.

[ILLUSTRATION OMITTED]

With C&J’s recently completed $6.8 million expansion, we
have increased our Medical Manufacturing capacity by 50%. C&J has 46
presses that range from 20 tons to 720 tons of clamping pressure.
C&J now offers three Class VIII clean rooms for Molding and one
class VII Assembly clean room. We provide a full suite of secondary
services: Pad Printing, Sonic Welding, Solvent Bonding and Tray Seal
packaging.

In addition to this, C&J offers a unique 10-Year mold warranty
that reflects the high quality of the plastic injection molds that we
produce. Our warranty is extended to any production injection mold
produced by C&J Industries, regardless of the quantity produced. Our
ISO and FDA certifications and unique warranty adequately display our
commitment to the highest quality assurance standards.

The culture and commitment of C&J Industries can best be summed
up in our Mission Statement:

“C&J Industries will provide value to our customers
through the use of technology and engineering solutions. We will seek
customers that exhibit a reciprocal level of trust and a commitment to
succeed; to our mutual benefit.”

www.cjindustries.com

[ILLUSTRATION OMITTED]

Cadence, Inc.

9 Technology Drive

Staunton, VA 24401

Phone: 800-252-3371

Fax: 540-248-4400

E-mail: sales@cadenceinc.com

Web: www.cadenceinc.com

VITAL STATISTICS

Year Founded: 1985

Number of Employees: 323

Number of Facilities: 3

Annual Sales: $56 Million

WHO WE ARE

[ILLUSTRATION OMITTED]

Cadence is ranked among the top life science companies providing
outsourced design and manufacturing solutions for medical technologies
and scientific applications. Cadence’s unique position in the
surgical device and diagnostics markets comes from a 100% focus on
improving patient outcomes. This makes Cadence the strategic partner for
medical device OEMs seeking to improve outcomes through better product
performance. Our proprietary “sharps” processing technologies
enable Cadence to supply the most critical components and sub-assemblies
for medical devices, scientific, and industrial applications.

MAJOR MARKETS

* Analytical Science

* Cardiology

* Drug Delivery

* Fluid Delivery

* Interventional Therapy

* Neurology

* Orthopedics

* Biopsy

* Diagnostics

*
Endoscopy

 

* General Surgery

* Minimally Invasive Surgery

* Opthalmology

* Pharmaceutical

SERVICES OFFERED

[ILLUSTRATION OMITTED]

What makes Cadence different from other companies? Outcome-based
Manufacturing[TM]. Simply stated, we put the patient first and work hand
in hand with the most sophisticated device OEMs to define what is
required to help patients get better faster. We then build new
manufacturing processes required to produce these innovative new
products. Providing what the patient needs to get better faster by
building the optimized processes needed to make it happen. This is
Outcome Based Manufacturing[TM]. We create manufacturing technology the
world has never seen to make new devices the world has never seen.

We provide operational excellence in:

* Cleaning and Passivation

* Contract Manufacturing

* Custom Packaging–Assembly

* Design Engineering Assistance

* EDM–Sink and Wire

* Electro-Chemical
Edge Enhancement

 

* Forming–Deburring

* IncisionLab

* ISO 13485 and 9001 Registered

* Laser Cutting–Welding–Marking

* Machining–Swiss–Screw–CNC

* Micromachining

* Overmolding–Insert Molding

* Performance Enhancing Coatings

* Photo Elching

* Pointing–Needle and Wire

* Rapid Prototyping–“ADRENALINE”

* Sharpening–Grinding

* Stamping–Machining–Heat Treating

* Supply Chain Management

www.cadenceinc.com

Carclo Technical Plastics

600 Depot Street

Latrobe, PA 15650

Phone: 724-539-1833

Fax: 724-539-6620

E-mail: sales@carclo-usa.com

Web: www.carclo-plc.com

VITAL STATISTICS

Year Founded: 1924

Number of Employees: 832

Number of Facilities: 12

Annual Sales: $95 Million

WHO WE ARE

[ILLUSTRATION OMITTED]

Carclo Technical Plastics, a division of Carclo plc is an
engineering based company led by engineers coupling industry standards
with a Six Sigma culture specializing in injection molding and contract
manufacturing services. Operating out of twelve locations across the
United States, United Kingdom, Czech Republic, China, and India, the
synergy of Carclo provides an extensive list of technical capabilities
and global facilities, meeting the increasing logistical and cost
requirements of tomorrow. Carclo facilities are ISO13485:2003 certified
and FDA registered.

MAJOR MARKETS

More than half of the division’s turnover is from healthcare
applications with an additional quarter in optics products including a
proprietary line of LED optics. The largest heahhcare segment served is
diagnostics disposables with significant offerings in respiratory,
pharmaceutical, medical/surgical,
ostomy

, and ophthalmic products.

SERVICES OFFERED

Carclo’s ability to continuously develop leading edge
technologies means that our
core competence

 is forever growing. Our
capabilities stem from the design, manufacture and assembly of injection
molded components, making Carclo an innovative full service supplier.
Being a company of engineers, our unique operating model and technical
depth allow our customers to take full advantage of engineering services
from concept and design to sophisticated production and logistics
management.

[ILLUSTRATION OMITTED]

* Product Development

* Industrial and Mechanical Design

* Tool and Automation Design

* Automated Assembly

* Automated Packaging

* Tooling and Automation Construction

* In-Mold Labeling

* Plastic Gear Manufacturing

* Technology Transfer Programs

* Medical Device Assembly

* ISO 5,6,7, and 8 Molding and Assembly

* Anti-Scratch, Anti-Fog, and Hardcoating

*
Vendor Managed Inventory

 Programs

* Injection Molding

* Optical Design

* Twin Shot Molding

* Manual Assembly

* Prototype tooling

* Microfluidics

* IR Welding

* Ultrasonic Welding

* Direct Ship Programs

* UV Bonding

www.carclo-plc.com

[ILLUSTRATION OMITTED]

Cendres+Metaux SA

Rue de Boujean 122

CH-2501 Biel/Bienne

Phone: +41 58 360 20 00

Fax: +41 58 360 20 13

E-mail: info@cmsa.ch

Web: www.cmsa.ch/medical

VITAL STATISTICS

Year Founded: 1924

Number of Employees: 470

Number of Facilities: 2

Certifications: ISO 13485, 9001, 14001, FDA registered,
GMP
 (guanosine monophosphate): see guanine.
 compliant

WHO WE ARE

[ILLUSTRATION OMITTED]

We develop, produce, market and sell worldwide our own as well as
customer-specific products and services for various branches of the
industry. Over 430 employees combine traditional know-how with
innovative solutions ensuring the success of our customers. In the
Medical division, we turn customer requests into individual precision
products or systems. From idea to manufacturing and delivery of
ready-packaged medical devices. In our micromechanical manufacturing
facilities, high-tech machines transform the semi-finished products into
high precision components. Apart from precious metals and their alloys,
we also process pure titanium, titanium alloys and high-performance
polymers. One of our special strengths is the turning and milling of
components with diameters ranging from 42 mm to under 0.2 mm. Another of
the key skills of Cendres+Metaux is the surface treatment of medical
implants. Be it etching titanium, anodizing, passivating, coating, laser
marking, mechanical polishing or grit blasting, we have many different
options at our disposal.

MAJOR MARKETS

In order of importance:

* Dental implantology

* Ear-Nose-Throat

* Neurology

* Cardiology

*
Traumatology
 /trau·ma·tol·o·gy/ () the branch of surgery dealing with wounds and disability from injuries.


n.
 

SERVICES OFFERED

[ILLUSTRATION OMITTED]

Micro-machining of
homogenous

 high-quality precious metal and
titanium alloys

We excel in complex manufacturing assignments with tight tolerances
down to the smallest dimensions.

Processing of high-performance polymers (Pekkton[R] and OXPEKK[R])
The innovative, implantable, metal free solution for your devices.

Tailor-made surface treatments

From sandblasting to etching, anodizing or polishing; we do it all
according to your needs.

Complementary full-service operations

Including engineering, project management, laser marking, cleaning,
assembling (in clean room ISO class 8, if required), testing, packaging
(from simple peel pouches up to complex blisters) and inventory
management.

www.cmsa.ch/medical

[ILLUSTRATION OMITTED]

CIRTEC Medical Systems, LLC

101B Cooper Court

Los Gatos, CA 95032

Phone: 888-924-7832

Fax: 408-395-0465

E-mail: info@cirtecmed.com

Web: www.cirtecmed.com

VITAL STATISTICS

Year Founded: 1988

Number of Employees: 160

Number of Facilities: 2

WHO WE ARE

CIRTEC Medical Systems has decades of experience helping our
clients to design, develop and manufacture medical devices for the
Cardiovascular, Neurological, Gastrointestinal, Orthopedic, Ophthalmic
and Diagnostic Instrumentation sectors. Customers turn to CIRTEC to
implement solutions for minimally invasive systems, active & passive
implants and electronic systems. Our technical expertise, program
management, quality systems and production team can take your medical
device application from concept through clinical trials to volume
manufacturing, and everything in between. CIRTEC will address your
needs, meet your challenges, and execute your ideas on plan and on
budget the first time around.

MAJOR MARKETS

Markets: Cardiovascular, Neurological, Gastrointestinal,
Orthopedic, Diagnostic, and Ophthalmic Applications: Medical Device
Outsource Solutions for Minimally Invasive Systems, Active & Passive
Implants, Electronic Systems and Instrumentation

SERVICES OFFERED

Engineering Solutions:

* Mechanical:

–SolidWorks

–Injection Molded Part Design

–Fluid Flow Analysis and Design

–Reliability Engineering

–ProEngineer

–Structural Analysis–FEA

–Packaging Design

–Shape Memory Design

* Electronics:

–Analog/Digital/RF engineering

–Temperature Measurement and Control

–Microprocessor Design and Control

–Versed in
North American

 and EU Safety Standards

–UL60601/IEC 60601-1-1

–Motion Control Systems

* Software:

–Embedded Real-Time Software for machine/instrument control

–PC based Software (C and C++) for medical systems

–Test Systems for Research and Production

–Digital Signal Processing (
DSP

) Design

* Human Factors and Industrial Design

* Packaging and Sterilization

* Materials Analysis

* Chemistry

Development & Prototyping:

* Design Transfer:

–Collaborative Design Teams

–Design for Manufacturing and Assembly (DFMA)

–Scalable Pilot Manufacturing

–Design Verification

–Process Validation

* Prototype Builds:

–3D Modeling

–CNC Machining

–Industrial Design Foam Models

–Rapid Prototyping Capability

–Electrical Engineering Lab

–Chemistry Wet Lab

Manufacturing Solutions:

* Enterprise Capability:

–Enterprise Resource Planning:

–Distinct Engineering Capability:

–Development, manufacturing, tooling, sustained high volume
production

–Multiple
SKU

 tracking for family of product lines

–Mature, dedicated and skilled work force

–Multiple areas of competence for both small and large
manufacturing runs

* Process Excellence:

–Lean/Six Sigma

* Manufacturing Operations:

–Hermetic assembly: Laser marking, electrical assembly, vacuum
baking,
hermetic
 /her·met·ic/ () impervious to air.


 or her·met·i·cal
adj.
Completely sealed, especially against the escape or entry of air.
 welding

–Minimally Invasive Device Assembly

–Electromechanical Systems Assembly

–Coil Winding, Wire Stripping, Crimping

–Silicone Coating, Backfilling, Adhesion

–Cleaning

–Packaging and Labeling

www.cirtecmed.com

Classic Industries, Inc.

149 Devereux Drive

Latrobe, PA 15650

Phone: 724-537-9600

Fax: 724-537-2477

E-mail: sales@classicind.com

Web: www.classicind.com

VITAL STATISTICS

Year Founded: 1970

Number of Employees: 550+

Number of Facilities: 7

WHO WE ARE

[ILLUSTRATION OMITTED]

The Global Leader in Medical Injection Molding

Setting the Industry Standard

Classic Industries Inc. is a full-service world-class provider of
Injection Molded Components, Contract Design, Technical Manufacturing,
Assembly, Packaging and Logistics Services for the pharmaceutical and
health care markets. We are committed to continually providing our
customers with world-class products and services at competitive prices.
Our philosophy of continuous improvement enables us to initiate and
maintain long term partnerships with our customers.

MAJOR MARKETS

Medical Device and Regulated Healthcare

SERVICES OFFERED

[ILLUSTRATION OMITTED]

Our Advanced Engineering and Project Management capabilities
consist of:

* New Product Design

* Process Development

* Assembly

* Mold Design

* Tooling Coordination & Supplier Management

* In-house Tooling

* Complete Part Validation

* Packaging

* Logistics

* Rapid Prototyping

Our Global Footprint

[ILLUSTRATION OMITTED]

Coastal Life Technologies

1803 Grandstand Drive

San Antonio, TX 78238

Phone: 866-638-6118

Fax: 210-681-8015

E-mail: custserv@cltsa.com

Web: www.CLTSA.com

VITAL STATISTICS

Year Founded: 2000

Number of Employees: 120

Number of Facilities: 1–San Antonio Headquarters

WHO WE ARE

[ILLUSTRATION OMITTED]

Coastal Life Technologies is your streamlined solution for the
manufacturing and distribution of medical devices–from development to
routine production and beyond. We make time-and money-saving
contributions to manufacturing considerations that should be explored in
every phase of your product’s lifecycle.

We have a reputation for providing our clients with high quality,
sterile, single-use medical devices on time and within budget.

CLT

 is ISO 13485 certified and centrally located in
San Antonio,
Texas

, with an ISO Class 8 Clean Room.

www.CLTSA.com

[ILLUSTRATION OMITTED]

MAJOR MARKETS

We provide turnkey solutions for the manufacturing of medical
devices.

SERVICES OFFERED

Raw Material Management

CLT will manage the variety of raw materials needed to assemble
your device. We have the capability to source, purchase, receive,
inspect, and stock the components necessary for the final product.

Final Assembly and Sterile Packaging

All the necessary components are assembled and tested in an ISO
Class 8 Clean Room. We continue to monitor and optimize the
manufacturing processes to improve quality and decrease cost.

Sterilization

After assembly and sterile packaging is complete, CLT will
coordinate product sterilization through ISO-certified contractors
utilizing Gamma or
Ethylene Oxide
 Occupational medicine A gas used to sterilize medical supplies and other materials
 gas processes.

Warehousing and Order Fulfillment

CLT will store your products in our climate-controlled warehouse.
We seamlessly process the order for shipment to your customers through a
customized system that meets your needs. This eliminates the
non-value-added cost of shipping products from warehouse to warehouse,
simplifies the supply chain, and ultimately lowers your cost.

Process Development and Engineering Assistance

Our experienced and multidisciplinary team will work to develop and
validate the most efficient processes required to manufacture your
products using the latest assembly techniques and methodology. We have
expertise in providing front-end services such as design assistance,
prototyping, process development and clinical trial builds.

Comdec, Inc.

25 Hale Street

Newburyport, MA 01950

Phone: 978-462-3399

Fax: 978-462-3443

E-mail: cblanken@comdecinc.com

Web: www.comdecinc.com

VITAL STATISTICS

Year Founded: 1982

Number of Employees: 65+

Number of Facilities: 2

Annual Sales: $5–10 Million

WHO WE ARE

[ILLUSTRATION OMITTED]

Comdec is a contract printer that specializes in the Pad Printing,
and Screen Printing Process for the Medical, Automotive, and Electronic
Industry. We have printed over 500 million items since the doors were
first opened in 1982. We are housed in a 73,000 square foot facility in
Newburyport, MA. Our well-trained staff ensures that every order meets
your quality and delivery specifications with impeccable customer
service. We extend an open invitation to inspect our facility and our
controlled environment.

MAJOR MARKETS

Medical Device Products, Cosmetic Products, Electronic Devices,
Consumer Products, Baby Feeding Products, Automotive Products

SERVICES OFFERED

[ILLUSTRATION OMITTED]

Comdec offers a variety of contract printing options to meet your
needs. Screen-printing, pad printing, hot stamping, heat transfers and
laser marking are available to fulfill your requirements.

We offer specialized services, such as three controlled
environments within our 73,000 sq. ft. facility and pre-treatment for
adhesion to polyethylene and polypropylene. Both corona, flame pre
treatment and post cure systems are available. Silicone products are
another area of our expertise.

Choosing the correct or specified ink on a drawing is critical.
Whether your adhesion criteria are
autoclave

, scratch resistance, or
chemical resistance, Comdec follows strict guidelines to meet all
customers’ needs and commitments.

For those customers that require validation, traceability, and
accountability we follow strict guidelines to ensure your project meets
safety requirements.

www.comdecinc.com

[ILLUSTRATION OMITTED]

Command Medical Products, Inc.

15 Signal Avenue

Ormond Beach, FL 32174

Phone: 386-672-8116

Fax: 386-677-7781

E-mail: sales@commandmedical.com

Web: www.commandmedical.com

VITAL STATISTICS

Year Founded: 1987

Number of Employees: >100

Number of Facilities: 2 (Ormond Beach and Managua, Nicaragua)

Annual Sales: Undisclosed as the company is privately held

WHO WE ARE

[ILLUSTRATION OMITTED]

Command Medical is a disposable device manufacturer that supports
medical outsourced product lines from subassemblies to finished sterile
devices. Core competencies include RF Welding, tube extrusion, assembly,
packaging and sterilization management. With facilities in the US and in
Nicaragua, Command offers cost effective manufacturing options for
products at all stages of the product lifecycte.

MAJOR MARKETS

Command serves many markets with manufacturing of Class I and Class
II devices:

* Dialysis

* Blood/Tissue Storage

* Wound Management

* Fluid Collection and Storage

* Infusion Therapy

* Incontinence

* Surgical Supply

* Custom Devices

SERVICES OFFERED

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

Along with our core competencies, Command Medical Products, Inc.
offers a variety of
value added

 services and offerings including:

* Product Design Assistance: Design for manufacturing/alternate
parts sourcing

* Prototyping: sample runs/feasibihty testing

* Process Development: Validation and cost reduction programs

* Tooling Management: Tool design, management and maintenance

* Supply Chain Management: vendor consolidations/customized
inventory solutions

* Dock to Stock Product Delivery

* Gamma/Eto Sterilization

Our Management Team is comprised of an experienced staff
knowledgeable in all aspects of medical device manufacturing. Our Team
Leaders have over 100 years combined experience.

www.commandmedical.com

[ILLUSTRATION OMITTED]

Covidien

15 Hampshire Street

Mansfield, MA 02048

Phone: 508-261-8000

Fax: 508-261-8437

E-mail: matt.diohep@covidien.com

Web: www.covidien.com/cps

VITAL STATISTICS

Number of Employees: 41,000

Number of Facilities: 53 Facilities located in 16 Countries

WHO WE ARE

[ILLUSTRATION OMITTED]

The Covidien OEM and Custom Product Solutions Division is dedicated
to delivering high quality medical and custom engineered products to the
Medical Device, Pharmaceutical, Consumer, Rehabilitation, and Industrial
Markets.

Drawing from the diverse manufacturing capabilities of 53
manufacturing facilities worldwide, Covidien OEM offers our customers
and partners a single source for custom product design and development,
and one of the broadest standard product offerings in the medical device
industry today.

MAJOR MARKETS

Medical Device, Pharmaceutical, Biotech, Consumer, Rehabilitation,
Industrial

SERVICES OFFERED

Products Offered

* Needles and Syringes

* Hydrogels

* Stimulating and Specialty Electrodes

* Sutures

* Urology

* Chart and Thermal Papers

* Soft Tissue Wound Closure

* Skin Care

* Hot and Cold Therapy

* Wound Care

* Bioabsorbable Polymers

*
Thermometry

 

* Enteral Feeding

* Blood Collection

* Suction and GI

* Sharps Disposal

[ILLUSTRATION OMITTED]

Manufacturing Capabilities

* Injection Molding

*
Hydrogel

n.
A colloidal gel in which the particles are dispersed in water.


hydrogel

a gel that contains water.


 Wound care A polymer absorptive wound dressing. See Dressing.
 Mixing and Formulation

* Bottle/Syringe Filling

* Suture Braiding and Monofilaments

* Absorbable and Non-Absorbable Polymers

* Custom Converting

* Rigid and Flexible Packaging

* Ultrasonic Welding

* Die Cutting

* Textile Converting

* Extrusion

* RF Welding

* Electronic PCB Assembly

* Laminating

* Kit Manufacturing

* Electrode Assembly

www.covidien.com/cps

[ILLUSTRATION OMITTED]

Crescent Industries Inc.

70 E. High Street

New Freedom, PA 17349

Phone: 717-235-3844

Fax: 717-235-7481

E-mail: sales@crescentind.com

Web: www.crescentind.com

VITAL STATISTICS

Year Founded: 1946

Number of Employees: 151

Number of Facilities: 3

Annual Sales: $17.5 Million

Certifications: ISO 13485:2003 & 9001:2008

WHO WE ARE

[ILLUSTRATION OMITTED]

Crescent Industries is your dedicated injection molder for your
medical device project. They provide an integrated single source
solution for injection molding by offering design and development
services, mold building, injection molding and several value added
services to complete your project. Their tooling, molding and clean room
facility operates under the ISO 13485:2003 certified procedures. With
the use of automation, utilizing scientific injection molding
principles, and committed employee owners, they have the ability to
produce high quality components for their customers.

MAJOR MARKETS

Medical, Pharmaceutical, Dental and Life Sciences–products include
centrifuges, in-vitro diagnostics, cardiovascular, fixation devices,

prenatal care

n the health care provided the mother and fetus before childbirth.
, CT & MR products, gastro products, women’s
health care products, ophthalmology products and
otology
 /otol·o·gy/ () the branch of medicine dealing with the ear, its anatomy, physiology, and pathology.otolog´ic


n.
The branch of medicine that deals with the ear.
 products.

SERVICES OFFERED

Design & Development

* Product and Mold Design

* Mold Fill Analysis

* Prototyping

* Digitizing

* Material Selection

[ILLUSTRATION OMITTED]

New Mold Builds

*
SPI

 Class 101-105 Molds

* Single Cavity through Multi-cavity

* Mold Maintenance, Repair and Revision

Injection Molding

* Family Molding

* Custom Injection Molding

* ISO 8 Clean Room Molding

* Insert Molding

* Over Molding

Value Added Services

* ISO 7 Clean Room Assembly and Packaging

* Swiss Screw Machining

* Sterilization

* Silk Screening

* Heat Staking

* Parts Annealing

* Production Machining

* Ultra Sonic Welding

* Pad Printing

*
EMI

 Shielding

* UV and Air Cured Bonding

* Parts Cleaning

Quality

* Process Validation

* Design of Experiment

* IQ, OQ, PQ

* Capabilities Study

*
PFMEA

 and Process Control Plans

www.crescentind.com

[ILLUSTRATION OMITTED]

Cretex Medical–rms–rms Surgical–Meier–JunoPacific

8600 Evergreen Boulevard

Minneapolis, MN 55303

Phone: 763-786-1520

Contacts: for Metals: Dennis Olson

dolson@machine.com

for Plastics: Mark McCourtney

763-553-1312 m.mcourtney@junopacific.com

Web: www.Cretex.com

VITAL STATISTICS

Year Founded: Cretex–1917; rms–1967; Meier–1979;
JunoPacific–1954

Number of Employees: 1200+; rms 700+; Meier–70; JunoPacific–225

Number of Facilities: Cretex Medical 7; 5 MN; 1 CA; 1 TN

WHO WE ARE

Cretex Medical is a family of companies specializing in providing a
broad range of manufacturing solutions to medical device OEM’s.
Private ownership, a long term perspective and a strong financial
portfolio allow us to invest in the leading edge manufacturing
technologies and engineering resources required to meet today’s
launch critical timelines with confidence. Our family of companies
include rms, JunoPacific, Meier and rms Surgical; providing a wide range
of manufacturing capabilities including machining, plastic injection
molding, metal forming and clean room assembly and packaging.

MAJOR MARKETS

* Cardio-stimulation

*
Sports Medicine
 branch of medicine concerned with physical fitness and with the treatment and prevention of injuries and other disorders related to sports. Knee, leg, back, and shoulder injuries; stiffness and pain in joints; tendinitis; “tennis elbow”; and
 

* Drug delivery

* Cardio–peripheral vascular

* Orthopedic Implants and Instrumentation

* Neuromodulation

* Ablation therapies

* Endoscopic

* Hearing Health

SERVICES OFFERED

Capabilities:

* Design for manufacturing (
DFM

DFM Design for Manufacturability
DFM Dubai Financial Market
DFM Delphi Form
DFM Distinguished Flying Medal
DFM Diesel Fuel Marine
)

* Machining (milling, Swiss and conventional turning, and EDM)

* Laser cutting

* Press brake forming

* Silk screening and laser marking

*
Anodize
  
tr.v. an·o·dized, an·o·diz·ing, an·o·diz·es
To coat (a metallic surface) electrolytically with a protective or decorative oxide.


[anod(e) + -ize.
 

* Complete progressive metal forming capabilities (Stamping)

* Cost savings conversions

* Prototyping

* Turret punching

* Wire forming

* Electropolishing

* Tool design

* Laser welding

* Clean room molding

* Micro-molding

* Implantable Molding

* Sterilization case & tray design

* Secondary operations (buffing, deburring, blasting, passivation,
etc)

* Subassembly and assembly (automated and manual processes; Clean
room)

* Assembly

* ISO 13485 Certified

* Multi-shot Injection Molding

* Insert molding (incl. reel-to-reel)

* Header & Lead Component Molding

* Sterile packaging and labeling

* FDA Registered

Materials:

Metals and Alloys:

* Cobalt Chrome

* Inconel

*
Tantalum
  [from Tantalus], metallic chemical element; symbol Ta; at. no. 73; at. wt. 180.9479; m.p. 2,996&degC;; b.p. 5,400±100&degC;; sp. gr. 16.65 at 20&degC;; valence +2, +3, +4, or +5.
 

* Nitinol

* Medical Grade Stainless Steel (303,304, 316, 316L, and others)

* Titanium (all grades) and Ti Alloys

* Platinum and platinum alloys and other precious metals

* MP35N

* Paladium

* Tungsten

* other exotic metals

Polymers:

* All engineering grade
thermoplastic

 (filled and unfilled) and

thermoset

 resins, including:

* PEEK (Optima[R] and 450G[R])

*
Acetal
 /ac·e·tal/ ()
1. any of a class of organic compounds formed by combination of an aldehyde molecule and two alcohol molecules.

2.
 

* Polysulfone

*
LCP

 

*
PPS

 

* Tecothane (incl. implantable grades)

*
Polycarbonate

 (incl. implantable grade:

* Polysulfone

* Ultem[R]

*
PES
 () pl. pe´des   [L.]
1. foot.

2. any footlike part.


n. pl. pe·des
1. The foot.

2.
 

* Nylon

* Delrin[R]

*
UHMW

 polyethylene

*
PEK

PEK Punctate Epithelial Keratopathy
 

* TPEs, TPUs, TPRs

* Acetal

www.Cretex.com

Criterion Instrument

5349 West 161st Street

Brook Park, OH 44142

Phone: 216-267-1733

Fax: 216-267-4542

E-mail: office@criteriontool.com

Web: www.criteriontool.com

VITAL STATISTICS

Year Founded: 1953

Number of Employees: 26

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

Criterion Instrument is a precision machine shop producing
components for Class II & Class III medical devices. Criterion has
prototyped and produced precision components for use in medical
instruments, bone screws, surgical implants and diagnostic
instrumentation that support medical device companies and the
Biotech/Bio-med industries.

MAJOR MARKETS

Medical, Diagnostic, Biotech/Bio-med industries.

SERVICES OFFERED

Criterion has over 60 years experience in the machining of close
tolerance (+/-.0002) CNC milling, CNC turning and Swiss CNC turning of
high precision components from prototypes for proof of concept, small
production runs for clinical trials through production quantities.

[ILLUSTRATION OMITTED]

Criterion’s capabilities include the machining of many
difficult materials such as ultem and implantable grade titanium, as
well as stainless steel, aluminum, plastic, peek, inconel, brass,
hastelloy, nitinol and non-ferrous castings.

These various components help to service the needs of the
orthopedic, spinal, reconstructive, cardiovascular,
epidermal

Referring to the thin outermost layer of the skin, itself made up of several layers, that covers and protects the underlying dermis (skin).

Mentioned in: Antiangiogenic Therapy, Histiocytosis X


epidermal
, endocrine
and many other medical fields of study and research.

CNC Milling, CNC Turning, Swiss Turning, Prototyping, Certified
Qualily Assurance, FDA Registered, ISO 9001:2008, state of the art
equipment and facility–allow Criterion to be part of the solution for
your next project.

www.criteriontool.com

[ILLUSTRATION OMITTED]

DDL

, Inc.

10200 Valley View Road, Suite 101

Eden Prairie, MN 55344

Phone: 952-941-9226; 800-229-4235

Fax: 952-941-9813

E-mail: scott.levy@testedandproven.com

Web: www.testedandproven.com

VITAL STATISTICS

Year Founded: 1990 by John Hart and Patrick Nolan

Number of Employees: 55 employees within our three locations
throughout the United States

Key Personnel: Patrick Nolan, President; Corey Hensel, General
Manager; Scott Levy, Packaging Engineer; Patrick Waddick, Quality
Assurance Manager

WHO WE ARE

[ILLUSTRATION OMITTED]

For over two decades, DDL’s team of engineers, technical and
quality experts has helped customers worldwide succeed by providing
medical package, device and materials testing. DDL takes an independent,
involved, impartial and informed approach in order to ensure regulatory
compliance. We specialize in medical device package validation (ISO
11607) as well as testing the product in your package and the materials
your package is made of. Our three full service testing laboratories
provide the expertise to validate the efficacy of your packaging
systems. DDL has the quality system, staffing, equipment and, most
importantly, the expertise to help you make your critical testing
decisions. Your goal is an on time product launch. Our mission is to
make that happen.

MAJOR MARKETS

DDL serves the medical device, pharmaceutical, biotech and consumer
markets on a national level.

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

SERVICES OFFERED

* Shelf-Life Studies / Accelerated Aging

* Transportation / Distribution Simulation

* Sterile Barrier System Integrity Testing

* ISO 11607 Compliance Testing and Consulting

* Environmental Challenge Package Testing

* Sterile Barrier System
Strength Testing

n assessment procedure to determine the contractile strength of a muscle.
 

* Thermal Package Performance Testing

* Package and Product Stability Testing

* Product and Material Testing

* Small Volume Package Manufacturing

* Luer Testing

* Electrosurgical Accessory Testing

* Packaging Sustainability Compliance Consulting

www.testedandproven.com

[ILLUSTRATION OMITTED]

Donatelle

501 County Road E2 Extension

New Brighton, MN 55112

Phone: 651-633-4200

Fax: 651-633-5486

E-mail: info@donatelle.net

Web: www.donatellemedical.com

VITAL STATISTICS

Year Founded: 1967

Number of Employees: 400+

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

Donatelle is a leading custom and contract manufacturer serving the
medical industry, with special expertise in implantable devices. We
offer world-class experience in the areas of molding, machining, and
device assembly. Our Company is focused on assisting customers with
designing, developing, and manufacturing high-quality product.

MAJOR MARKETS

Donatelle serves many facets of the medical industry, including the
implantable component market. Some of the markets we serve include

cardiac rhythm management

, cardiovascular, cardiac surgery,
neuromodulation, spinal/orthpaedics, surgical technologies, and
diabetes.

SERVICES OFFERED

As a vertically-integrated contract manufacturer, Donatelle offers
progressive solutions to ensure successful product realization for
medical component manufacturing through device assembly, packaging, and
sterilization management. We are ISO-9001:2008 and 13485:2003 certified,
FDA compliant, and our manufacturing processes are validated according
to Quality System Regulation 21 CFR Part 820.

[ILLUSTRATION OMITTED]

At Donatelle, we believe early design involvement ensures optimum
component and product integrity. We partner with our customers and
provide them with a project team approach, and we employ the
industry’s best engineers and technical experts to assist with
product design and development. These industry experts work diligently
with our customers every step of the way. If needs include prototyping
or rapid tooling, Donatelle can provide near net shape samples with
typical tolerances of [+ or -] 0.005″ within a turnaround time of 4
days to 2 weeks, dependent on design complexity.

Donatelle offers expert processing capabilities for the entire
range of engineered resins. Our production floor operates 24 hours a
day, 7 days a week and houses over 40 molding machines that range from
5- to 300-ton capacity. Molding is performed in controlled environments
and cleanrooms, and is monitored by our
ERP

 System which has a direct
interface with our primary processing equipment for optimum throughput.

We also offer precision machined component fabrication. Donatelle
specializes in close tolerance components and is experienced in working
with a wide variety of materials. Processes available in-house at
Donatelle include Swiss CNC including multiaxis Swiss machining centers,
wire EDM work cells that are robotically controlled for full 24/7
unattended operation, vertical machining with full 5-axis simultaneous
machining, and micro machining with CNC milling, turning, and EDM.

If your device requires validation, Donatelle is the supplier you
can trust! We understand what is required by the FDA. Our technical
experts are experienced in process validation methodologies, validation
sampling techniques,
Geometric Dimensioning and Tolerancing

 (GD&T),
scientific process development, and sterilization management.

With medical breakthroughs occurring faster than ever, you need
absolute confidence in products you bring to market. Whether it is
adherence to product specifications or regulatory requirements,
Donatelle understands this perfectly. We utilize our expertise to
deliver products that prove themselves through accuracy, repeatability,
and reliability.

www.donatellemedical.com

Eagle Stainless Tube & Fabrication Inc.

10 Discovery Way

Franklin, MA 02038

Phone: 800-528-8650

Fax: 508-520-1954

E-mail: generalsales@eagletube.com

Web: www.eagletube.com

VITAL STATISTICS

Year Founded: 1982

Number of Employees: 70

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

[ILLUSTRATION OMITTED]

Franklin, Massachusetts based Eagle Stainless Tube &
Fabrication, Inc. is celebrating its 31st year of operation serving
customers in medical, aerospace and high tech manufacturing. With a
record of on-time delivery, fair pricing, product quality and highly
skilled employees dedicated to continuous improvement and training,
Eagle has earned its reputation as a supplier of choice of off-the-shelf
stainless steel products and fabricated stainless steel components. With
Eagle as an ISO 9001, ISO 13485, and AS 9100 certification and Six Sigma
initiative driven manufacturing plant, you can be assured that every
member of our staff is concerned with the quality of every product at
every step of its journey through our plant.

MAJOR MARKETS

* Medical

* Aerospace

* High tech manufacturing

SERVICES OFFERED

* Stainless steel tubing shipped from extensive inventory (Tubing,
Bar Stock, Hollow Bar, Pipe, Flanges, Fittings, Custom Sizes and Shapes)

* Precision cut-to-length tubing

* Custom fabricated stainless steel components

* Custom shaped and sized tubing

* Stainless steel metric tubing

* Square and rectangular tubing

* Bending, Cutting, CNC Machining, Laser Welding & Cutting,
Grinding, Assembly, and more. Eagle specializes in Stainless Steel, High
Nickel Alloy and Titanium Components.

There is no Voicemail!

When you call Eagle expect to talk with a friendly professional who
speaks your language and is prepared to respond to your needs. Whether
you need specifics on our capabilities or details on our inventories,
you will get answers immediately!

Eagle’s redesigned and updated website is user friendly. It
includes more downloads, more options with RFQ’s, and updated
information about our services. Go to www.eagletube.com

www.eagletube.com

[ILLUSTRATION OMITTED]

ECA

 Medical Instruments

1107
Tourmaline
 , complex borosilicate mineral with varying amounts of aluminum, iron, magnesium, sodium, lithium, potassium, and sometimes other elements,
 Drive

Newbury Park, CA 91320

Phone: 805-376-2509

Fax: 805-376-2189

E-mail: info@ecamedical.com

Web: www.ecamedical.com

VITAL STATISTICS

Year Founded: 1979 (an American Capital Company)

Number of Employees: 30+

Number of Facilities: 2-40,000 sq. ft. for design, rapid
prototyping, manufacturing

Registrations: ISO 13485 registered

WHO WE ARE

ECA Medical Instruments[R] is the leading designer and manufacturer
of single-procedure torque limiting, fixed driver and other surgical
instruments and kits to the medical implant industry and surgeons
worldwide.

Medical device designers, doctors and patients alike rely on ECA
precision torque instruments in the O.R. each day to safely secure
critical implant device leads, fasteners, screws and connectors.
Original equipment manufacturers, including the world’s largest
medical device and heahhcare companies, turn to ECA as the trusted
surgical solution for disposable torque instruments and kits in the
Cardiac Rhythm Management, Cardiovascular, Neuromodulation, Orthopaedic,
Spine, Cranio-Maxillofacial and Trauma markets.

Since 1979, the company has designed and delivered nearly 20
million single-use instruments to our OEM and private label customers
resuhing in over 500 million precise and flawless surgical actuations.
That famihar ECA instrument quality feel and ‘click’ insures a
secure connection is made–one patient at a time.

At ECA we work with our OEM and healthcare partners to design,
build and support private label and branded disposable torque
instruments and kits to meet their exacting specifications. Our expert
team of engineers, designers and project managers collaborate with our
global customers to create high quality, cost effective instruments and
kits that provide sustained value and measurable competitive advantage.

Medical device products and implants require torque ranges from a
few oz./in, for CRM and Neuro applications to over 90 lb./in, or 10 Nm
for various orthopaedic procedures. ECA offers a complete family of
disposable torque instruments, products and kits for either off-the-
shelf, private label or fully custom solutions for medical device OEM,
healthcare partner and government agency applications.

SERVICES OFFERED

[ILLUSTRATION OMITTED]

ORTHOPAEDIC INSTRUMENTS AND KITS. ECA makes torque limiting
instruments and surgical procedure kits ranging from 2 lb./in.–90
lb./in. (0.224-10 Nm). Standard, custom and private label T-Handle,
Axial and Palm style torque limiting instruments are available as well
as standard and Wick-Away[TM] fixed drivers. The company also designs
and makes complete disposable surgical kits for specific orthopaedic
procedures including
ACF

, small bone sets, general ortho implant kits
and more.

[ILLUSTRATION OMITTED]

CRANIO-MAXILLOFACIAL (
CMF

CMF Code Monétaire et Financier
). ECA torque limiting instruments and
kits for CMF procedures are tailored to the exacting specifications of
our OEM customer and healthcare partners. ECA provides a wide range of
torque solutions for various CMF procedures to secure implant plates and
devices to treat CMF reconstruction and orthognathic surgery.

[ILLUSTRATION OMITTED]

TRAUMA INSTRUMENTS & KITS. General purpose and specialized
single-use trauma kits with precision torque limiting instruments and
related devices are available from ECA. Our OEM and healthcare partners
can employ our off-the-shelf trauma kit or tailor for their specific
applications and procedure.

Single-Procedure Value & Benefits

The company’s medical grade engineered, precision performance
and cost effective torque instruments and kits offer unequalled quality
by design solutions. Cost responsible[TM] and high quality disposable
torque limiting instruments and kits are helping transform the
healthcare industry. The sustained benefits and value of single-use or
disposable surgical torque products vs. costly reusable wrenches
include:

* Guaranteed precision torque calibration

* Best total cost of ownership

*
Biocompatibility
 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2.
 

* Improved logistics handling and savings

* Reduced risk of patient infection

* Pre-sterilized, simplified operation, ease of use

* Improved sustainability

* Lower life cycle cost

www.ecamedical.com

Elcam Medical Inc.

2 University Plaza, Suite 620

Hackensack, NJ 07601

Phone: 201-457-1120

Fax: 201-457-1125

E-mail: info@elcam-medical.com

Web: www.elcam-medical.com

VITAL STATISTICS

Year Founded: 1970

Number of Employees: 400 with over 20 Engineers

Number of Facilities: 7 (within Israel, US, and Italy)

WHO WE ARE

Elcam Medical is the worldwide leader of disposable medical devices
for the OEM market, and a provider of innovative solutions for
specialized flow control needs. Elcam works with the medical
industry’s leading companies, with particular expertise in the
areas of Fluid Management and I.V. Therapy, Vital Signs Monitoring,
Hemodiatysis, and Drug Delivery.

In an effort to continuously broaden our product lines while
remaining committed to quality and customer care, Elcam Medical acquired
a majority interest in Colorado-based Injectech in 2009 and acquired
Lucomed SPA, located in
Carpi
  
n.
Plural of carpus.
, Italy, in 2010. Through our acquisitions
we are now able to offer a one-stop- shop for our customers, expand our
manufacturing capabilities, and deliver products for all their flow
control needs.

Our customers include large to small medical device and
pharmaceutical companies worldwide. For over 40 years, Elcam has
consistently provided high quality products at competitive prices and
delivered on time.

MAJOR MARKETS

Elcam’s innovative solutions are designed to truly meet our
customers’ needs and provide you with differentiating advantages
IV-Therapy & Anesthesia, Patient Monitoring, Interventional
Cardiology& Radiology, Hemodialysis Injectable Drug Delivery.

SERVICES OFFERED

Our Products:

* Stopcocks–standard 1, 2, 3, and 4-way, antimicrobial, swabbable,
large bore, high pressure, and lipid resistant. Many custom options are
available (i.e.: handle types, handle colors, etc.)

* Manifolds–standard and custom options available.

* Needleless–slit
septum
 /sep·tum/ () pl. sep´ta   [L.] a dividing wall or partition.


alveolar septum  interalveolar s.
 Y-Sites, luer locks and luer slip
injection sites and locking and straight cannulas

* High pressure rotating adapters

* Angiographic and
PTCA

abbr.
percutaneous transluminal coronary angioplasty


 Percutaneous transluminal coronary angioplasty, see there
 valve devices

* Disposable pressure transducers and flush devices

* Auto-injectors for pharmaceuticals

* Caps–vented and non-vented

* Male and female locking connectors (mini and large bore)

* Spikes–vented and non-vented

* Clamps–slide and pinch clamps

* Y-Connectors–3-12 ways

* Drop Chambers–small, medium, and large

[ILLUSTRATION OMITTED]

Our Advantage:

* One-stop-shop

* Unparalleled customer experience

* Clinical know-how and expertise

* State-of-the-art design and manufacturing capabilities

* Consistent quality for over 40 years

* Global presence

* On-time delivery

Our Capabilities:

* Customization

* High-volume precision injection molding

* High-speed automated assembly

* Laser drilling

* LIM molding

* Soldering

* Packaging

* Hand assembly

* Design and development

* Ultrasonic welding

* Regulatory and QA

* Class 100K cleanrooms

* Tubing extrusions

[ILLUSTRATION OMITTED]

Newest Capabilities:

* Subassembly services

* Tube assembly

* Mold making

Please visit our website (www.elcam-medical.com) for more
information on our components, sub-assemblies, and complete turnkey
solutions. Experience Elcam–where everything connects!

www.elcam-medical.com

EtQ, Inc.

399 Conklin Street, Suite 208

Farmingdale, NY 11735

Phone: 516-293-0949

Fax: 516-293-0784

E-mail: info@etq.com

Web: www.etq.com

WHO WE ARE

[ILLUSTRATION OMITTED]

EtQ, Inc.

Founded on March 4, 1992 by former lead auditors of Underwriters
Laboratories, EtQ has always had a unique knowledge of compliance
processes related to GMP, Quality, Safety, and Environmental Health and
Safety Management. EtQ uses best in class integrated modules and
enterprise application integration to manage and measure compliance
processes and execute organizational change. EtQ’s solution,
Reliance, is an enterprise suite of modules designed to foster
operational excellence in businesses with modules and utilities such as
eMDR, Complaint Handling, Risk Management, CAPA, Document Control,
Employee Training, Supplier Rating, Audits, and many more. EtQ has been
providing software solutions to a variety of markets for 20 years.

MAJOR MARKETS

EtQ’s FDA Compliance Management Software is an integrated
Quality and Compliance Management system that has been pre-configured to
specifically address the needs of the Life Science industry. EtQ’s
unique modular approach provides unparalleled flexibility and
automation, delivering a best in class solution.

SERVICES OFFERED

Streamlined Compliance Process Using Risk Register EtQ’s
unique FDA Compliance Software System is designed to minimize the number
of CAPAs using an advanced filtering model, which features:

* Automatic segregation and categorization of events at the source

* Automatic identification and display of related events

* Initial assessment to allow early closure

* Risk assessment throughout the process to guide decision-making

* Fuji investigation with step-by-step root cause analysis

* Automatic lookup and display of related investigations and CAPAs

* Comprehensive CAPA and effectiveness check plan with risk
mitigation history

Corrective and Preventive Action

 

EtQ’s FDA Compliance software can generate a Corrective and
Preventive Action request that routes through review, root cause,
corrective action taken, and verification stages. Multiple reports are
generated automatically providing an effective mechanism for tracking
the source and costs of problems.

Change Management

EtQ’s Change Management module is designed to manage all
aspects of the Change Management process. Change Management integrates
with other key modules such as Risk Register to analyze the impact of
change, and Complaint Handling to identify adverse events, analyze
change feedback, and collect customer requirements for future changes.

Compliant Handling

Complaint Handling Management Software manages complaint handling
in compliance with FDA guidelines. It records all complaints reported by
customers or consumers to investigate the problems and keeps records of
these complaints. Complaint Handling Software also provides an
electronic form, for adverse event reporting.

Audits

EtQ’s Audits module automates the process of auditing and
surveying, including internal audits and customer satisfaction surveys.
Some key user definable features include: checklists, question library,
evaluation method (numerical scoring or counting), and more.

eValidation

EtQ offers an automated validation module that shortens the
company’s validation time by as much as 400 percent-a 4 day
validation project can be done in less than a day using EtQ’s
eValidator. Furthermore, the eValidator can be run by a single employee,
and can eliminate the extensive resources needed to dedicate to a
typical validation project. Finally, eValidator is able to compile a
comprehensive report library of all tests and scripts run on the system.
When audited by the FDA or other governing body, the validation reports
are immediately available for review.

www.etq.com