FDA updated its guidance related to standards recognition on 17-Sep-2007. The full document is at the link provided. It describes requirements for the declaration of conformity description and discusses documentation required and limitations of use of consensus standards. This is relevant for use of software standards such as ISO 62304 as well as all other relevant standards.
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.
