FDA Issues Revisions to Recognized Standards

FDA issued the annual update to its list of recognized standards. The full list is at the link provided. While there have been no changes or additions to the general medical device software standards, there are some additions to IVD related computer and laboratory information systems, networking, and interface standards, as well as withdrawals and updates to several of the IEC 601 series standards.

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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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