Free

MDR Classification Wizard

Classify your medical device step-by-step following EU MDR Annex VIII rules. Get a clear risk class (I, IIa, IIb, III) with the supporting rationale and applicable rules.

  • All 22 classification rules covered
  • Annex VIII rule references
  • Exportable classification report
  • MDCG guidance alignment
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Free

Submission & Document Tracker

Track regulatory submissions and organize your technical documentation across your entire medical device portfolio. Monitor status from draft through approval with full audit trail.

  • EU MDR and FDA submission types
  • Status workflow (Draft → Approved)
  • Document management per submission
  • Portfolio overview dashboard
  • Full change history and audit trail
Open Tracker

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