“Lessons from 342 Medical Device Failures” by Dolores R. Wallace and D. Richard Kuhn of NIST examines software related recalls for medical devices and their possible causes and preventive measures.
“Lessons from 342 Medical Device Failures” by Dolores R. Wallace and D. Richard Kuhn of NIST examines software related recalls for medical devices and their possible causes and preventive measures.
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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