At public conferences representatives of FDA have indicated that the draft Medical Device Data System Classification rule was returned from FDA legal review for clarification of how public comments were addressed. This will delay release of the final rule perhaps 3-6 months, but this is hard to estimate.
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.
