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ISO 13485 Procedure: QP-854 Product Recall and Advisory Notices

M00027366

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ISO 13485 Procedure: QP-854 Product Recall and Advisory Notices

Training Material by 9000 Store, 2008

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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.

Features/Benefits: Addresses the Medical Device Report, outlines responsibilities of the Compliance Administrator and Committee, and covers Recall/Advisory Notices. Contents:
Customizable ISO 13485 Product Recall and Advisory Notices Procedure Corrective/Preventive Action Request Form