Day

November 26, 2022
This Playbook was prepared by The MITRE Corporation and the Medical Device Innovation Consortium using funds from the U.S. Food and Drug Administration in November 2021.  Download playbook here:  Playbook-for-Threat-Modeling-Medical-Devices-2021 The playbook is not prescriptive in that it does not describe one approach to be used when threat modeling medical devices. It is intended to...
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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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