The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)” provides the mandatory requirements for auditors to ensure they are competent, impartial, and spending enough time doing their audits, especially where medical devices present a higher risk to patient safety.

 …