I've been informed that part of our 510k submission is our quality manual. Given that over half of the information in the manual does not apply to the submission (there are no submission details on operations, manufacturing, service, purchasing, etc.), I would think that the quality processes that apply to the submission would be the only things to submit. It seems to me that giving more information just delays the analysis of the submission and opens the door for extra questions. What's the common/accepted practice for including the quality manual or "extra" processes not related to the requested submission pieces?
Thank you.
S. Schoepel
Thank you.
S. Schoepel