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Submission readiness
Regulatory submission readiness for medical device teams
VigilySys helps teams see evidence completeness before submission planning, partner review, or notified-body conversations.
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.