QCC focuses on regulatory documentation and evidence packaging. We can help interpret and integrate testing results you already have (or plan), but we do not replace a sponsor’s testing execution responsibilities.
FDA 510(k) Cybersecurity Docs
Does QCC perform cybersecurity testing?
What deliverables do you provide?
Deliverables may include submission-ready cybersecurity narratives, SBOM documentation, risk/threat modeling summaries, lifecycle vulnerability management documentation, and traceability artifacts formatted for FDA review.
What inputs do you typically need from a sponsor?
Typical inputs include device architecture and software design documentation, third-party component inventories (for SBOM), cybersecurity risk analyses or threat models, existing cybersecurity testing artifacts (if available), and your intended submission format (e.g., eSTAR).
Who is FDA 510(k) cybersecurity documentation support for?
This service supports manufacturers of software-enabled or connected medical devices and SaMD preparing an FDA 510(k) submission where cybersecurity documentation is required or expected.