ISO 13485:2016 P-833 Product Recall and Advisory Notice

ISO 13485:2016 Procedure – Product Recall and Advisory Notice – describes the process used to determine and control the recall and withdrawal of medical devices for cause, the issuance of advisory notices, and generation of regulatory reports, if required. Addresses the Medical Device Report, outlines responsibilities of the Compliance Administrator and Committee, and covers Recall/Advisory Notices.

Published:

2019

File Size:

1 file , 480 KB