Are complaints applicable to development of medical devices?

#1
Hi,

It is my first post on this forum, but I read a lot on the various topics you discuss and it was always useful.

My company provides medical device design and development services. We do not manufacture anything. Once he development is completed, it is transfered to our client who is the manufacturer of the device.

I wonder if I need to maintain a complaint procedure since we are not engaged in post market activities. Only development.
The case I struggle with is the following:
Let's say we assemble a prototype and deliver it to the client for Validation testing for example. If the client notices a deficiency (that classifies as a complaint) related to the prototype we delivered, should I treat it as a complaint ? Or is it part of Validation activities ?

Thanks.
 
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#2
Welcome to the Cove. Since you are not the Device Manufacturer, you have no responsibilities for 21 CFR 820.198 (assuming US FDA compliance). I agree that feedback on prototypes is part of your Development process. If the prototype failed a test from your client, that should be under the scope of a particular protocol, the issue would be reported, investigated and fed back into the Design process for resolution. Hope this helps.
 
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