These two draft standards for networked medical devices and for medical device software risk management have been renumbered IEC 80001-1 and IEC 80002-1 respectively. IEC 80002-1 was released for a 3 month ballot period Jan 16, 2009.
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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