A new draft of the international “Medical device software – Software life-cycle processes” has been released for comments. This standard is based on the ANSI/AAMI U.S. national standard SW68 which it is intended to replace. The comment period ends April 30, 2004 and the draft is at the link provided.
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.
