The International Medical Device Regulators Forum (IMDRF) issued a final document “Software as a Medical Device(SaMD): Key Definitions” on December 9, 2013. IMDRF SaMD def
The International Medical Device Regulators Forum (IMDRF) issued a final document “Software as a Medical Device(SaMD): Key Definitions” on December 9, 2013. IMDRF SaMD def
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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