IEC 62366 CDV-1 Amendment Draft for Review

AAMI/CDV-1 62366:2007/A1 (IEC/SC62A/826/CDV) — Medical devices – Application of usability engineering to medical devices, Amendment 1.
This amendment is out for comment and addresses legacy user interfaces and 62366 conformance for User Interfaces of Unknown Provenance (UOUP).

The 62366 amendment draft can now downloaded free from AAMI. Go to the AAMI web site at the link provided (http://marketplace.aami.org/eseries/PDFDocs/62366AD1012.pdf) or search standards for 62366.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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