FDA has issued a revised guidance “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)” dated Dec. 31, 2012. TThe full guidance is at the link provided.
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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