This document provides answers to questions that have been asked to notified bodies regarding using EN 62304 for regulatory purposes in the EU. FAQ 62304
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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