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.
IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software
ISO 14971 Risk Management (typically with heavy emphasis on software aspect)
IEC 81001-5-1 Cybersecurity Lifecycle
ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits
Being Agile Yet Compliant (AAMI TIR 45)
IEC 29119-1 Software and System Testing
US Classification for Software Devices
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.
