Two questions :
1) Do most companies place this under Post Market Surveillance Activity?
2) Is this required even with a locked "non-learning" algorithm? We intend to submit a 510(k) for each AI change to market.
------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets -
https://www.twitch.tv/edosani------------------------------