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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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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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