FDA Adds Recognition for Several SW/HIT standards

FDA added the following standards to their recognized standards list and published the new recognitions January 2015.
IEC TR 80001-2-5 2014. Application of risk management for IT networks incorporating medical devices–Part 2-5: Application guidance–Guidance on distributed alarm systems.

IEEE Std 11073-10425- Health informatics 2014. Personal health device comunication, Part 10425: Device Specialization–Continuous Glucose Monitor (CGM).

LOINC 2.48 2014-06-27.Logical Observation Identifiers Names and Codes (LOINC).

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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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