Release Candidate justification and regulatory authorization

Hello,
We develop medical device software. We have such long waiting times for the return of the NB (authorization for the marketing of a new version) that we plan to release a Release Candidate to a restricted number of users/customers, informing them of the particular framework of this release (not approved by regulations but V&V achieved, no unacceptable residual bugs, information to the users...). Purpose of the release candidate: to collect user feedbacks and validate in a clinical context.

In your opinion, is it acceptable in regulatory terms, and what recommendations would you make?

Thank you.

Basically it's a work-around approach which is limited in time and number of clients.
This needs to be reflected in your internal documentation - design and development plan, ECOs etc.
And obviously there is an operational cost for running this validation effort. Hopefully you will get a valuable feedback and capture some bugs before the formal release after NB approval.

Good luck.
Shimon

The software cannot be used in a clinical context, no matter how few customers use it or how restricted the release is, unless it's part of a clinical investigation.