John Murray FDA’s Device Center Part 11 expert gave an update on Part 11 electronic records and signatures at AdvaMed Medical Technology Software Conference that was held on November 8-9, 2006 . His slides are at the link provided and discuss the direction being considered for revising the regulation, narrowing scope, and reducing it prescriptive nature.
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.
