Evidence before inference. Challenge before conclusion.
MDARIX works above your existing systems of record to reconstruct product reality and make investigation intelligence inspectable.
The principles behind every screen.
Keep existing systems of record.
Understand relationships across lifecycle information.
Investigate across connected context.
Separate facts, interpretations, hypotheses, and decisions.
Test the leading explanation against contradicting evidence and alternatives before it becomes a conclusion.
AI-assisted answers show the evidence they used and flag anything unverified.
AI supports investigation. Authorized humans make controlled decisions.
Grounded intelligence with visible limits.
MDARIX preserves evidence references, temporal context, contradictions, unknowns, provenance, and human review. AI does not create the final regulated decision.
- Answers cite the authorized evidence they were built from.
- When evidence is thin, MDARIX holds back instead of guessing.
- No unsupported root-cause claims; interpretation stays separate from observation.
- Authorized humans review, decide and sign.
- AI is switched on per organization by its administrator. It is off in the free trial while it is validated, and every step works by hand.
FDA, EU MDR, UK and Canada reporting windows, and the standards whose evidence MDARIX organizes. MDARIX does not certify compliance: your quality system and its validation stay yours.
See the regulationsControlled, separated by organization, and traceable by design.
Authentication, role and field authorization, action controls, provenance, and human authority form the current security foundation. Independent certification is not claimed.
Each organization's data is scoped to it on every request and enforced by the database (row-level security).
Authenticator-app MFA (single sign-on is planned), sign-out after 30 minutes without activity, a 12-hour limit on any session, and immediate sign-out when access is suspended.
Role-based access, approval authority by role, segregation of duties, and protected platform roles.
What MDARIX can accurately say today.
These statements describe controls in the product today. They are not certification claims.
Authorization scoped to each organization, role and field policies, audit records, provenance, human approval controls, and advisory AI safeguards are built into the product.
MDARIX is not yet a validated (GxP) system. Design-partner pilots use exported records without patient-identifiable information, and your systems of record stay authoritative.
MDARIX does not claim ISO 27001 certification, HIPAA compliance, GDPR compliance, or 21 CFR Part 11 compliance on this site.
Validation protocols, test reports, and approved non-confidential sample dossiers may be shared during a controlled review. No confidential customer material is published.
Work above the systems you already trust.
QMS, PLM, ERP, MES, supplier, document, and evidence platforms remain authoritative systems of record.
- Start with file exports from your existing systems; live connections are built in a pilot.
- Versioned, governed mappings from your fields to the MDARIX model, released with approval.
- Source-system API keys are encrypted at rest and never shown again.
Bring one real investigation. See the whole story in one place.
Start with exports from your quality, product and supplier systems. Your systems of record stay where they are.