IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
Clause 9: Process requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) MD 9.6.2.2: Review adverse event notifications, advisory notices and recalls in surveillance

What does MD 9.6.2.2 require?

The surveillance programme includes, beyond ISO/IEC 17021-1 clause 9.6.2.2, a review of the actions the client has taken on notification of adverse events, on advisory notices and on recalls.

Maintained by Gerard Blokdyk

Other controls in Clause 9: Process requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)

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MCP endpointAll IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) controls