P
Perry2018
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!
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!