Mould ing. . . innovative design solutions . . . . . prototypes to development . . . . . to your needs and requirements

Del iver ing. . . a full outsourcing service . . . . . quality in manufacturing and service . . . . . your products to market

SAMPLE PRODUCTPORTFOLIO

Self Expanding Stent•Delivery DevicesPercutaneous Heart Valve•Delivery DevicesCardiac Rhythm•Management ComponentsInfusion Finished Devices•Implantable Orthopaedic•ComponentsIntrauterine Devices•Tracheostomy Components•and BalloonsNebulisers•Blood Glucose Monitoring •Neurovascular Surgical •Finished Devices•

MEDICAL MARKETSWE SERVE

Vascular•Drug Delivery•Orthopaedics•Cardiology•Respiratory•Endoscopy•Wound Care•Diabetes Care•General Surgical•Infusion Disposable Devices•Prenatal Care•Ambulatory Pain Relief•BioTech•

Development Process

5

4

Tooling • Market Entry Tooling• Single to Multi Cavity• Fully Hardened • Insert Moulding

Industrial Design• User Need • Des ign Research• Human Factor Research• Trend Analysis• Concept Generation• Prototyping/Models

1

2

3

Production/Finished Device Manufacturing • Clean Room Injection Moulding• Multi-Shot Injection Moulding • Low to High Volume Capabilities • Value Add Services

a. GMP Finished Device Manufacturingb. Sterilisationc. Printing

Qualification• Process Qualification (IQ, OQ, PQ)

• Sterilisation Validation• Biocompatibility Testing • CE Submission• Shelf Life Testing

Mechanical Design• Detail Design• Design for “X”• Material Selection• Cost Matrix• FEA/Mouldflow• Controlled Drawings

• Prototypinga. 3D Printingb. Urethane Castingc. Machined Models

• Design Validation & Verification

Complete Service Offering• Prototyping

a. 3D Printingb. Urethane Castingc. Machined Models

• Design Validation & Verification

ProTek Medical is a full service outsourcing Design & Manufacturing partner to the HealthcareIndustry. Specialising in GMP Clean Room Injection Moulding & Finished Device Manufacturing, wepartner with customers from pre-submission phases right through to production. This innovativepartnership approach ensures that optimum part design is achieved, robust tooling is manufacturedand a highly capable production process is developed.

At ProTek Medical, Clean Room Injection Moulding is at the core of what we do; by applying ourexperience and understanding we use scientific moulding principles to provide customers with a turn-key solution in Injection Moulding that includes Tool Design, Tool Transfer, Clean Room InjectionMoulding and GMP Clean Room Finished Device Manufacturing.

ProTek Medical has a proven expertise in the Healthcare Industry by partnering with leading MedicalDevice and Pharmaceutical Companies since 1995.

Why Choose ProTek?• Delivery – ProTek continuously delivers a world class service to our customers. We strive to provide on

time delivery in all areas of our business from NPI to manufacturing. Partnering with leading OEM’s, we

have built a reputation of strength, quality and innovation in the Healthcare Industry.

• Strong Customer Relationships – Through the use of cross functional teams and dedicated project

management, our customers benefit from reduced overall project lead times and excellent customer service.

• 100% Medical Focused – ProTek is dedicated to the Healthcare Industry and has proven experience and

success in delivering a knowledgeable and reliable service to our customers.

• Scalability – With our proven track record in Injection Moulding, we have ample capacity to continue

our growth and investment in our facility.

• Quality – Certified to ISO13485, we are committed to supplying products and services to the Healthcare

Industry that meets or exceeds customer requirements. We continuously improve our systems, processes,

cost effectiveness, and at all times maintain the effectiveness of the Quality Management System.

• Tool Qualification Process – ProTek continue to deliver superior value and quality through our robust

and proven Tool Qualification Process.

• Innovative Partner – Committed to your development, we provide a dedicated innovation team at

pre-clinical design stages. Our innovation team consist of design, manufacturing and quality engineers

to deliver a reliable and manufacturable solution that will accelerate your position in the market.

The Science Of Injection Moulding

ProTek Medica l - Mou ld ing Ideas, De l i ver ing So lut ions

For more information on how ProTek can help you, please contact:

ProTek Medical Ltd. Finisklin Business Park, Sligo, Ireland

Tel: +353 (0)71 9171808 Fax: +353 (0)71 9171810 Email: info@protek.ie

www.protek.ie

� Established in 1995� Privately Held Company� 100% Medical Focused� 55,000 Square Foot Facility� Class 10,000 & Class 100,000 Clean Rooms

� ISO 13485 Certified