See the ONC 10-year roadmap to achieving a “learning health system” based on an interoperable health IT ecosystem at the link provided. ONC 10 year Interoperability Concept Paper
See the ONC 10-year roadmap to achieving a “learning health system” based on an interoperable health IT ecosystem at the link provided. ONC 10 year Interoperability Concept Paper
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.