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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.
What makes medical device
manufacturing at ControlTek
diferent?
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
Certifed 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 98682
TF: (866) 818 - 9855 | Vancouver: (360) 896 - 9375 | Portland: (503) 242 - 3526
www.controltek.com

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