The presentation “Quality System Regulation 21 CFR 820 Basic Introduction” by Kimberly A. Trautman CDRH Medical Device Qualtiy System Expert at FDA is a brief overview of this central regulation for medical device manufacturers with some extra emphasis on Design Control elements. The full presentation 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.
