hi,
We have just been audited by our NB, just as our CE Mark was up for renewal. I have submitted responses to their findings and am awaiting the approval and subsequent return of our CE Mark for our medical device.
In the meantime can we manufacture any medical devices and quarantine them awaiting return of our CE Mark as we are doing everything to approved procedures and we do have our ISO 13485 certificate?
Thanks
We have just been audited by our NB, just as our CE Mark was up for renewal. I have submitted responses to their findings and am awaiting the approval and subsequent return of our CE Mark for our medical device.
In the meantime can we manufacture any medical devices and quarantine them awaiting return of our CE Mark as we are doing everything to approved procedures and we do have our ISO 13485 certificate?
Thanks