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SaMD compliance
SaMD compliance evidence workspace
Software as a Medical Device teams need evidence chains that connect intended use, software requirements, risk controls, verification, usability, privacy, and cybersecurity.
What this page is for
This solution page is for teams that need practical evidence readiness, not generic document storage.
Evidence domains connected
- Device context and intended use.
- Requirements and design inputs.
- Safety, cybersecurity, privacy, and usability risks.
- Risk controls and verification evidence.
- Submission readiness gaps and owner actions.
What VigilySys is not
VigilySys is not a replacement for your QMS, RIM system, SBOM scanner, regulatory consultant, or notified-body/FDA decision-making. It is the workspace that keeps evidence chains coherent.
Common questions
Is VigilySys a QMS?
No. VigilySys complements QMS workflows by organizing device evidence and traceability before formal quality-system approval.
Does VigilySys replace regulatory consultants?
No. It gives teams and advisors a clearer evidence workspace for review, gap closure, and handover.
request a demo to turn this topic into a practical evidence-gap view for your device context.