EN 62304 FAQ

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

SoftwareCPR Training Courses:

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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