IEC 62304 and IEC 60601-1 3rd edition were harmonized in the European Union on November 28. A claim of compliance with 62304 now provides a presumption of conformity with the MDD and AIMDD for software. In addition, 62366 – application of usability engineering to medical devices has also been harmonized.
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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