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What does risk management entail?

Risk management encompasses many areas:

  • Threat modeling: MDIC/MITRE Threat Modeling Playbook

  • Cybersecurity risk assessment: Postmarket Cybersecurity Guidance

  • Controls

  • SBOM and supporting info: NITA SBOM Framing Document

  • Testing: FDA Recognized standards AAMI/UL 2900-1:2017, Clauses 13-19 or IEC 81001-5-1: 2021, Clauses 5.5-5.7

  • Unresolved anomalies: Premarket Software Guidance

  • Traceability

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