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13485 P-833 Product Recall and Advisory Notice

Procedure - Product Recall and Advisory Notice - Includes form: F-852-001 Corrective/Preventive Action Form.

Format: MS Word
Language: English
Product Type: Digital
Provider: 13485 Store

Price: $35.00
Product Details

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.

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