Medical Device Cybersecurity Documentation Kit (FD&C Act 524B)

Not eligible for NQT documentation review.

Medical Device Cybersecurity Documentation Kit (FD&C Act 524B)

A threat model worksheet, an exploitability-based security risk assessment that links patient-harm items to your ISO 14971 file, an SBOM inventory with end-of-support and vulnerability flags, a postmarket vulnerability log, a 524B/guidance documentation checklist, a cybersecurity management plan, a CVD policy and a labeling checklist.

What's inside:

- 00_Start_Here_README.pdf

- 01_Med_Device_Cybersecurity_Workbook.xlsx

- 02_Cybersecurity_Management_Plan.docx

- 03_CVD_Policy_Template.docx

- 04_Security_Labeling_Checklist.docx

Templates, not regulatory advice. Standards are paraphrased and cited by clause number only; buy them from their publishers.

Written by Matt Norman: 15 years as a U.S. Navy aviation structural mechanic, then 3 years at SpaceX as a Falcon 9 quality inspector and QA supervisor, with hands-on experience working under ITAR and DoD compliance requirements. Norman Quality Tools is Veteran-Owned & Operated.

License: one company, all sites. Word/Excel 2016+, Microsoft 365, LibreOffice. No macros.

More kits at normanqualitytools.com

Templates, not regulatory advice.

Norman Quality Tools is not affiliated with or endorsed by the U.S. FDA, AAMI, IEC, SpaceX or any other current or former employer of the author, or any other standards body, government agency or company named in this description. Does not guarantee certification or approval.

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