At what stage does Design Control play a role in Medical Device Development

C

coolvar

#1
At what stage does design control play a role in the development of medical device (polymer).?
Does it start when the device is in the final stages of R&D or only after it enters manufacturing?
What if the medical device needs to be customized for every customer ?
Thank you
 
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somashekar

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#2
Re: Design control in medical device

At what stage does design control play a role in the development of medical device (polymer).?
Does it start when the device is in the final stages of R&D or only after it enters manufacturing?
What if the medical device needs to be customized for every customer ?
Thank you
Hello coolvar...
Welcome to the elsmar.com forums and a good opening question from you.
Design inputs are perhaps the first point of design control stage in the development of medical device.
After it enters manufacturing, the design control takes place as in 7.3.7 Control of design and development changes.
When you customize design for every customer, you take the customer requirement into the design input and use all the design information and learning of other similar designs to take it through all the design stages.
 
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