Resources
Free checklists & templates
Working checklists you can copy straight into your QMS. Vendor-neutral, no email gate, MIT-style usage.
6 min · 30 items
Premarket
FDA Premarket Cybersecurity Submission Checklist
Section-by-section checklist mirroring FDA's RTA cybersecurity items: security risk management, SBOM, threat model, testing evidence, labeling, and CVD policy.
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5 min · 23 items
SBOM
SBOM Quality & VEX Readiness Checklist
What every cybersecurity reviewer (FDA or hospital) looks for in an SBOM: format, depth, signatures, hashes, supplier identification, and paired VEX statements.
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7 min · 30 items
Postmarket
Postmarket Vulnerability Response Template
A working PSIRT playbook: intake, triage with CVSS + clinical impact, communication, fix, regulatory reporting, and lessons-learned loop.
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