For those using or interested in the SEI’s Capability Maturity Model, the link provided contains a white paper comparing IEC 62304 and the CMMi. This white paper was prepared by David Walker, a consultant that is a licensed SEI partner. It is published here with his permission.
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.
