In an AAMI Webinar John Murray of FDA indicated that it appears that software issues comprise 16 percent of medical device recalls and there is some thought to developing some special procedures for handling these. SoftwareCPR has found approximately 75 recalls related to software as of the end of November 2007 for the year which is about the same total as 2006 for the year.
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.
