ISO 13485 Procedure 854-Product Recall and Advisory Notices

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.

File Size: 94.5 KB
Format: Word
Language: English
Product Type: Procedures
Provider: 13485 Store

Price: $39.00
Product Details


  • Addresses the Medical Device Report, outlines responsibilities of the Compliance Administrator and Committee, and covers Recall/Advisory Notices.


  • Customizable ISO 13485 Product Recall and Advisory Notices Procedure
  • Corrective/Preventive Action Request Form

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