This slide provides a timeline that identifies some of the key documents related to regulation of software for medical devices, pharmaceuticals, and biologics. It shows clearly the increasing focus on software validation in recent years.
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
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