Is there a regulatory or compendial requirement to keep an actual physical representation of each medical device model or is the Device Master File containing the specifications adequate?

Thanks

Is there a regulatory or compendial requirement to keep an actual physical representation of each medical device model or is the Device Master File containing the specifications adequate?

ThanksI don't know what compendial means and I am not aware of a regulatory requirement, but it sure is sound business practice to keep an actual device.

That is my opinion as well so I am playing the Devil's Advocate here a bit...

Why is it a good business practice?

Thousands of dollars are tied up in not only equipment that could be sold but in storage of the devices.

The Engineering Group will say that all that is needed is a set of specifications and mechanical drawings.

There is not any regulatory requirement to retain an actual prototype. You are required to retain device master records for any marketed device. Those describe all pertinent features etc. Some companies keep retains especially for batch production but that is not required. The emphasis in 820 and 13485 is retention of records not actual parts.