controltek medical device design & manufacturing flyer

2
E n g i n e ering B i om e d ica l El e ctr omec h anical Medica l D e vic e s F D A 5 1 0 K C ontr o l T e k Ele ctronic s Tek M E D I C A L DEVICE Design & Manufacturing As an expert electronic medical device design and manufacturer , we deliver your products to commercialization through: • Data driven accountability via proven manufacturing and development processes. • On time delivery at optimal cost. Incorporating Design For Manufacture (DFM) and Design For Test (DFT) throughout the development process. Experienced Manufacturing Proven Development Processes Innovative Technology ControlTek designs & manufactures electronic medical devices. We bring your device from concept to commercialization faster. to Your Marketplace DELIVERING Quality, Passion, & Service

Upload: controltek

Post on 29-Mar-2016

214 views

Category:

Documents


0 download

DESCRIPTION

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. For more information about ControlTek's manufacturing capabilities for the medical industry, please read the Medical Device Design & Manufacturing Flyer.

TRANSCRIPT

Page 1: ControlTek Medical Device Design & Manufacturing Flyer

E ngineering

Biom

e dical

Electrom

echa

nical

Medical D

evices

  FDA 510

K

                 Con

trolT

ek 

Electronics

Tek  M E D I C A L  DEVICE Design &   M a n u f a c t u r i n g

““

As an expert electronic medical device design and manufacturer, we deliver your products to commercialization through:

• Data driven accountability via proven manufacturing and development processes. • On time delivery at optimal cost. • Incorporating Design For Manufacture (DFM) and Design For Test (DFT) throughout the development process.

Experienced Manufacturing Proven Development Processes Innovative Technology

““

ControlTek designs & manufactures electronic medical devices. We bring your device from concept to commercialization faster.

to Your Marketplace

DELIVERINGQuality, Passion, & Service

Page 2: ControlTek Medical Device Design & Manufacturing Flyer

Tek  M E D I C A L  DEVICE Design &   M a n u f a c t u r i n g

What makes ControlTek’s electronic medical device design & manufacturing group unique?

• Over 30 years of award winning manufacturing capabilities leveraged with in-house engineering & product development.• We utilize a variety of testing methodologies that focus on delivering the highest quality product manufactured at the lowest possible cost.• Upfront risk analysis combined with continuous process improvement and quality metrics performed on all medical devices we design and manufacture.• A company culture of product success through a proven quality system.

3905 NE 112th Avenue | Vancouver, WA 98682TF: 866.818.9855 | Vancouver: 360.896.9375 | Portland: 503.242.3526

w w w . c o n t r o l t e k . c o m

ControlTek enables medical companies to get their product commercialized.

design

prototype

pre-production

production

MARKETPLACE

CONC

EPT

R e g u l a t o r y C o m p l i a n c e

We Can Assist At Any Point in the Product Life Cycle Whether you are starting with an idea or a final design, ControlTek can help bring your product to market.

ControlTek is a FDA registered facility and supports 510k submissions.