Trinity Biomedical supports the medical device industry through cleanroom assembly, machining, washing, automation, and staff expertise to provide single components or entire devices with fast time to market. They offer ISO-certified class 6-8 cleanrooms, various manufacturing capabilities, and aim to be a global leader in creating and producing medical components through quality and continual improvement.

2. COMPANY OVERVIEW
Trinity Biomedical supports the Medical Device industry by specializing in cleanroom
device assembly, CNC wireforming, advanced machining, automated ultrasonic
washing and passivation, systems automation building, along with a technically
advanced staff.
With Trinity's broad array of capabilities, foremost attention to quality, responsiveness
and lean operation we can either supply a single component or the entire device with
a speed to market timeline matched by few.
Trinity offers a state-of-the-art US Fed STD 209E Class ISO-6 / ISO-7 / ISO-8 cleanroom
dependent on your needs and requirements. Trinity is supported by ISO 9001-2008
and ISO13485; we are also AS-9100 compliant.
Trinity supports volume requirements from one to thousands of articles. Sourcing your
needs to Trinity Biomedical provides you the means to quickly accomplish the
development and manufacturing of medical devices for today’s global markets without
major investments of people and capital within your organization.

3. TRINITY BIOMEDICAL’S PATH TO
SUCCESS
Our Vision
Trinity Biomedical, Inc. will strive to be a global leader in the creation
and production of medical components to meet the needs of the medical
device industry.
Our Mission
Our Team is committed to supporting the medical manufacturing
industry resulting in an improved quality of human life.
Our Quality Policy
Trinity Biomedical is committed to surpass all of our customer’s quality
expectations through effective quality objectives and an enthusiastic
drive to continually improve all aspects of the organization.

4. OUR TEAMS
QUALIFICATIONS

5. • Med device experience since 1965
• 22 years CNC medical machining
• 22 years cleanroom assembly
• 22 years medical wire forming
• 28 years medical wire EDM
• 49 years medical tooling
• FDA regulatory experience
ISO 9001:2008
ISO 13485:2003
ISO 146144.1 Class 6
Cleanroom
AS-9100 Compliant
QUALITY
CERTIFICATIONS
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6. OUR STATE OF THE ART
FACILITY

7. • 52,000 ft2 Manufacturing facility
• Class 1000 – 100,000 Cleanroom
• Lab Testing – Particulate,
Non-Volatile, Residue
• CMM/Laser Scanning Inspection
• Statistical Process Control
• Reverse Engineering
• Product Research & Development
• Rapid Prototype Development

8. OUR PROCESSES

9. • CNC Milling & Swiss Turning
• Multi-Sonic Washing & Citric Passivation
• Dynamic Waterjet
• Wire EDM
• Wire & Spring Forming
• Metal Stamping
• Cleanroom Assembly & Packaging
• Warehouse & Distribution

10. CNC MILLING & SWISS TURNING
Trinity Biomedical is heavily invested in modern CNC machining
equipment. We have advanced the process of prototype and
production stage quantities of medical components to new levels
of speed and precision:
• Machine travels up to 85”X 50” X 36” (x, y, z).
Parts up to 116” long.
• Spindles up to 20,000 RPM for true, high speed machining.
• 1000 PSI thru-the-spindle coolant. Drilling speeds up to
7x faster than with HSS drills.
• Shrink-fit tool holders for the ultimate in machine tool
accuracy and rigidity.
• Software tool-path can reduce cutting times up to 50%.
• Tool position tolerances are generally to within 0.0005“.

11. WATER JET CAPABILITIES
Trinity Biomedical’s dynamic, abrasive water jet cutting system brings
high tolerance, rapid cutting to a new level. This versatile 4-axis head
provides 3-dimensional cutting head movement.
Its 60,000 PSI, dynamic cutting head can provide reduced cutting
times and provide walls with zero taper. Edges are smooth, heat-zone
free and accurate to within 0.003”.
We are experienced in cutting steel, aluminum, titanium, brass,
composite material, glass, plastic, ceramic tile, rubber, granite, and
marble.
Capable of material cut up to 9" thick with a table travel of 6' x 12’.

12. WIRE EDM
As a full service EDM source, we specialize in precision machining with quick
turn-around using the following:
• State-of-the-art submersible machines w/ automatic wire threading
• 30” x 20” x 14” machine travel
• Wire Ø down to 0.004”
• EDM Drilling Ø 0.008 to 0.250”
• Solid Modeling
• In-house block prep & heat treat.

13. WIRE FORMING
Trinity Biomedical has 22
years of experience in Wire
Forming:
• Wind Wire, Coil Wire, Form
Wire as small as 0.002 inch.
• Tension and Pitch Controls,
along with variation w/in single
wound or coiled length.
• Cannula Reinforcement Wires
• Coil-Reinforced Tubing for
Catheters
• Introducer wires, Suture snare
wires
• Compression / Extension /
Torsion springs
• Exotic materials specialists:
Titanium, Inconel, Beryllium,
Elgiloy, Chrome Vanadium, AL
Vanadium, AL 286, etc.
• Electroplating, Tumbling, Shot
Peen & Passivation

14. Trinity Biomedical manufactures springs for a range of medical
device applications including:
Various surface treatments are available including:
• Implants
• Hearing Aids
• Pacemakers
• Urology Manufacturing
• Pumps
• Dispensers
• Diagnostics Equipment
• Monitoring Device/Devices
• Guide Wires
• Tempering, hardening & annealment
• Ultrasonic cleaning, passivation, deburing & shot peening
• Zinc, Electro polish, phosphate, powder coating and color topcoat
SPRING MAKING

15. Since 1965 Trinity Biomedical has had experience in the production
Medical Metal Stampings. From Progressive, Transfer or Draw dies we
have the experienced toolmakers to get you the die you need.
• Complex, intricate and close tolerance components
• Short, medium and high production volumes
• Titanium, Inconel, beryllium and other exotic metals
• Rapid prototyping
METAL STAMPING

16. At Trinity Biomedical, we place significant emphasis on
Rapid Prototyping response for our customers.
Whether it is a precise machined component, an intricate
stamping, a medical instrument or a first-to-market
assembly, we are here to quickly respond to your needs
and requirements.
For the medical industry, we
specialize in the following types
of prototyping:
• Surgical tools / instruments
• Medical devices
• Medical components
• Hypo- Tubes Implants
• Medical Poly Drape sealing
• CNC machined, waterjet, EDM components
• Stampings, springs and wire forms
RAPID PROTOTYPING

17. Trinity Biomedical is an industry leader in ultrasonic
washing. Our state-of-the-art washers are capable of U/S
frequencies of 25, 40, 72 and 104 kHz.
Water purity is the key ingredient to the success of our
process. Using a Reverse Osmosis de-ionized water
treatment system capable of achieving 18 meg ohms of
purity, we are a leader in the field of washing.
Trinity has capabilities to qualify all of our washing
techniques using one or all of the following test methods:
• Particulate testing
• Non-volatile residue testing
• Testing for bio burden & endotoxin
MULTI-SONIC WASHING

18. Trinity Biomedical offers a citric acid passivation
service within an ISO Class 6 Cleanroom suitable
for implantable components.
CLEANROOM PASSIVATION

19. Trinity Biomedical assembly options include:
• Medical Device & Instruments
• Multi-Component Assemblies
• Thermo Soldering
• Ultraviolet Gluing
• Tig / Mig Welding
• Laser Welding
• Medical Kits
• Surgical Kits
• Emergency Kits
CLEANROOM ASSEMBLY

20. Our ISO 14644.1 Class 1000 cleanroom provides high level manufacturing,
cleaning and packaging capabilities. Trinity Biomedical offers years of
experience in the assembly of ultra fine wires, guidewires, catheters,
electronics, aerospace and machined medical devices.
Trinity Biomedical cleanroom packaging options include:
• Package Design Development
• Manual Bagging
• Kit Packaging
• Bulk Packaging
• Tray Sealing
• Skin Pack
• Coating
• Pouch Sealing
• Labeling
CLEANROOM PACKAGING

21. OUR PRODUCTS & SERVICES

22. Trinity Biomedical houses a convertible Class 1000
– 100,000 clean room for your Ultrasonic Washing /
Passivation, assembly and packaging requirements.
We are capable of handling all your production
programs as well as managing the entire process
from prototype through production. Programs are
run in secure private assembly rooms when
requested.
Services Offered Include:
• Medical Device Washing and Assembly
• Precision Contract Manufacturing
• Precision Component Assembly
• Clean Room Packaging Services
• Contract Ultrasonic Washing & Packaging

23. OUR PRODUCT
DEVELOPMENT
& MANAGEMENT

24. Early Trinity Biomedical involvement with your product at the
initial design stage can yield enhanced quality and
functionality to new product developments. Improved
manufacturability and optimization of material usage have
the potential to generate competitive advantages to your
Company.
Critical elements within the design and management
stages include:
• Refinement of Customer Goals into Final Product
• In House Design – SolidWorks and AutoCad.
• Extensive Knowledge of Metrologic Functions
• Fixture and Process Qualification and Validation
• Tool Procurement with Design Oversight
• In-House Project Management
• In-House Designers

25. OUR MEDICAL COMPONENT
IMAGES

28. OUR AFFILIATIONS

30. OUR ULTIMATE GOAL &
OBJECTIVE

31. We leverage our 49 years experience, our accumulated lean
manufacturing practices, innovation and technology, so that
we deliver our to customers quality components within
industry leading timelines.
We Absolutely
Stand Behind
Our Products &
Commitments
Tom McAdams, General Manager
tmcadams@trinitybiomedical.com
Cell: 262-389-2458
Office: 262-252-4786
Fax: 262-252-4791