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What is expected in a Medical Device Commercial Release Procedure

#1
Hi,

I have been tasked with generating and implementing a commercial release procedure for class I & II medical devices. This would take place when the device has been manufactured and produced and is ready to be released to the market so needs sign off by various departments.

Currently, we have a procedure where QA, RA & the project manager sign off a circulated release form agreeing that certain documentation is in place for the release. However, I do not believe the current procedure is fit for purpose.

Can anyone shed some light on what exactly is expected in a commercial release procedure from a regulation point of view? Can I get hold of an example of a medical device release procedure so I can grasp the main points and the departmental responsibilities in the release procedure.

Thanks!
 

yodon

Staff member
Super Moderator
#2
Not sure of where you distribute product, but here are excerpts from the FDA regulation and from 13485:

From 820:
§820.80 Receiving, in-process, and finished device acceptance.
...
(e) Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:
(1) The acceptance activities performed;
(2) the dates acceptance activities are performed;
(3) the results;
(4) the signature of the individual(s) conducting the acceptance activities; and ...

Then from 13485:
8.2.6 Monitoring and measurement of product

Evidence of conformity to the acceptance criteria shall be maintained. The identity of the person authorizing release of product shall be recorded

So with those in mind...

I have been tasked with generating and implementing a commercial release procedure for class I & II medical devices. This would take place when the device has been manufactured and produced and is ready to be released to the market so needs sign off by various departments.
The "sign off by various departments" is only true if your internal procedures require it. It's not wrong, just goes beyond what the regulations / standards require.

Currently, we have a procedure where QA, RA & the project manager sign off a circulated release form agreeing that certain documentation is in place for the release. However, I do not believe the current procedure is fit for purpose.
Why?
 
#3
Thank you for your reply.

We sell our medical devices globally, mainly Europe & USA.

Should QA be the final sign off for commercial release? Currently am undecided as to when QA should be involved in commercial release.
 

yodon

Staff member
Super Moderator
#4
The regulations / standards aren't prescriptive as to who has to sign off. It's pretty typical that Quality takes on that responsibility and usually for the reason of independence (which then often leads to conflicts between Quality and Manufacturing). Whomever does sign off is attesting for the company (and as authorized by management) that the product meets specification. Not a trivial responsibility that should be assigned to someone who could be pressured into signing off just to meet deadlines.
 
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