Assess · MedoQi AI Solutions
GapSmart AI™
Detect Intelligently. Comply Confidently. AI-assisted regulatory gap assessment and remediation intelligence, with clause traceability, severity ranking and specialist validation.
The problem
Gap assessments against the MDR, IVDR, ISO 13485 or QMSR are slow, repetitive and inconsistent between reviewers. Large portfolios make it worse.
Typical inputs
- Technical documentation
- QMS procedures and records
- GSPR checklists and prior audit findings
- Target requirement set: MDR, IVDR, ISO 13485 or QMSR
Outputs
- Clause-by-clause gap report
- Severity ranking
- Remediation plan with owners
- Traceability from each finding to clause and source
Workflow
How an assessment runs
- 01Load and selectDocuments loaded and the requirement set chosen.
- 02AI screeningContent mapped to clauses; potential gaps flagged with the source passage.
- 03Specialist validationEach finding confirmed, corrected or rejected, and rated by severity.
- 04Report and planValidated gap report and remediation plan issued.
- 05Re-assessmentRemediated documents re-checked to confirm closure.
Human review control
Only specialist-validated findings appear in your report.
Illustrative output · fictitious IVD file
| Clause | AI finding | Specialist decision | Severity |
|---|---|---|---|
| IVDR Annex XIII §1.2.3 | No justification for omitting a clinical performance study | Confirmed, finding reworded | Critical |
| IVDR Annex I §9.1 | Precision data cover a single reagent lot | Confirmed | Major |
| IVDR Annex II §1.1 | Basic UDI-DI not stated | Rejected: stated in section 1.4 | — |
Talk to our experts
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.