controltek medical device design and manufacturing

2
Electronic Manufacturing Services Provider Medical Device Manufacturing ControlTek works with leading medical companies to develop and deploy FDA-approved medical electronic devices. Our design process meets FDA requirements and supports 510k provisions.

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ControlTek designs & manufactures electronic medical devices. We bring your device fromconcept to commercialization faster.www.controltek.com

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Page 1: ControlTek Medical Device Design and Manufacturing

Electronic Manufacturing

Services Provider

Medical Device Manufacturing

ControlTek works with leading medical companies to develop and deploy FDA-approved medical electronic devices.Our design process meets FDA requirements and supports 510k provisions.

Page 2: ControlTek Medical Device Design and Manufacturing

What makes medical device manufacturing at ControlTek different?

• Integrated Engineering & Manufacturing

• Upfront Risk Analysis and Continuous Improvement

• A Quality System that covers every aspect of Manufacturing & Design Engineering

• Test Development & Documentation including Test Fixture Validation

Your medical products will be designed and manufactured using:

• FDA Registered, ISO 13485:2003 Certified Design & Manufacturing

• Design for Manufacture (DFM) and Design for Test (DFT) incorporated throughout Development

• Quality Requirements that can be Integrated with your own

3905 NE 112th Avenue Vancouver, Washington 98682TF: (866) 818 - 9855 | Vancouver: (360) 896 - 9375 | Portland: (503) 242 - 3526

www.controltek.com