Six documents covering FDA 2023 cybersecurity guidance, SBOM requirements, vulnerability management, and coordinated disclosure — built for QA and RA professionals who need audit-ready documentation now.
For QA managers and RA leads at medical device companies.
FDA's 2023 final cybersecurity guidance and the Omnibus Section 524B requirements created a new documentation burden overnight. SBOM, threat models, postmarket surveillance plans, and CVD policies are now mandatory — not optional. Submissions without them are getting Refuse to Accept (RTA) notices.
Most QA teams have deep QMS expertise but limited cybersecurity documentation experience. This toolkit bridges that gap with ready-to-customize templates that match exactly what FDA reviewers expect to see.
From premarket submission through postmarket surveillance and incident disclosure.
FDA 2023 cybersecurity guidance-aligned risk management plan covering threat modeling, risk assessment methodology, cybersecurity risk controls, and residual risk documentation. Maps to IEC 81001-5-1 and AAMI TIR57.
NTIA-compliant SBOM template for medical devices covering component inventory, version tracking, known vulnerability mapping, and FDA premarket submission formatting. Supports CycloneDX and SPDX formats.
Standard operating procedure for continuous vulnerability monitoring, NVD/CVE tracking, patch assessment, and remediation timelines. Covers FDA postmarket cybersecurity expectations and coordinated disclosure obligations.
Complete checklist for FDA 510(k) and PMA cybersecurity submissions per the 2023 final guidance. Covers threat modeling documentation, SBOM, software architecture diagrams, and cybersecurity testing evidence requirements.
Structured postmarket surveillance plan for ongoing cybersecurity monitoring, threat intelligence integration, incident response triggers, and FDA reporting thresholds under the Omnibus cybersecurity provisions.
Complete CVD policy template covering researcher submission intake, triage criteria, response timelines, patch development coordination, and public disclosure process. Aligns with ISO/IEC 29147 and FDA CVD expectations.
Every document aligns to FDA's final 2023 cybersecurity guidance for premarket submissions and postmarket management. Built for the current regulatory environment, not the 2014 draft.
The SBOM template covers FDA's required minimum elements, supports CycloneDX and SPDX formats, and includes CVE mapping fields. Stop building from scratch when FDA asks for it.
Most toolkits cover one phase. This one covers the full lifecycle: submission documentation, ongoing surveillance, vulnerability management, and incident disclosure.
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“We were preparing our 510(k) submission when FDA published the 2023 cybersecurity guidance. This toolkit had the SBOM template and submission checklist ready to go — our RA lead said it saved us at least three weeks of documentation work before the deadline.”
“The CVD policy alone was worth the price. We had a security researcher contact us with a vulnerability and had no process in place. This document gave us the intake form, response timelines, and disclosure protocol we needed to respond professionally.”
“Our notified body flagged missing postmarket cybersecurity documentation during our EU MDR technical file review. The Postmarket Surveillance Plan and Vulnerability Monitoring SOP closed both gaps in one pass. Clear, auditor-ready format.”
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