Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems
Document issued on: March 16, 2004
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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