Extensions | Aligned Elements - the Medical Device ALM

Medical Device Cybersecurity Risk Assessment Templates

The Medical Device Cybersecurity Risk Assessment template pack contains:

- RVT templates defining Assets, Threats, Vulnerabilities and their associated Adverse Impacts and Counter Measures as well as a corresponding Word Reporting style templates in A3 format

- Over 30 importable best practice cybersecurity mitigations

This allows the manufacturer to conduct Cybersecurity risk assessments in line with the FDA cybersecurity guidelines as will as the AAIM TIR 57 and include the risk assessment design controls in the overall development traceability.

Unzip the downloaded file. Place the rvt and docx file in your template folders. Import the xml file containing the Cyber Security Measures into Aligned Elements. When importing this extension, make sure that the "Recreate chapters" option is selected in the import dialog.

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