Hi all,
We got feedback from FDA that the submission should include a list of all unresolved software anomalies for our devices (Moderate Level of Concern).
But we believe that all the bugs or defects have been solved before the product release.
Can you please share your experience on handling this problem?
Many thanks,
Roland
We got feedback from FDA that the submission should include a list of all unresolved software anomalies for our devices (Moderate Level of Concern).
But we believe that all the bugs or defects have been solved before the product release.
Can you please share your experience on handling this problem?
Many thanks,
Roland