The IMDRF Management Committee approved the final N12 document, “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations”. IMDRF publishes their documents at the link provided. This document should be posted in the near future. FDA participates actively in the International Medical Device Regulators Forum (IMDRF) which is seeking to harmonize international regulation.
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.
