The attached second half of the presentation at the link provided were presented by FDA’s CDRH Software Compliance and Part 11 expert John Murray slides were presented at a UCI course. They present CDRH’s “software message” providing intent and background and the current focus in software regulation.
IEC 62304 and other Emerging Standards Impacting Medical Device Software
Being Agile & Yet Compliant
ISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.
