ReguLabs

Built for EU medical-device teams

Your MDR evidence should tell one connected story.

ReguLabs brings requirements, risks, clinical claims, verification evidence, and post-market work into one controlled workspace. Your team can see what supports what and what still needs attention.

Open secure workspace Follow the evidence chain

Human decisions stay accountable. AI assistance stays cited and reviewable.

Device evidence chain Reviewable
  1. 01
    RequirementGSPR 10.1

    Chemical and physical properties

    Linked
  2. 02
    Risk controlRC-014

    Material specification and verification

    Verified
  3. 03
    EvidenceEV-028

    Biocompatibility test report

    In review
  4. 04
    Controlled decisionPRRC sign-off

    Release with accountable approval

    Pending
Trace coverage3 of 4 checkpoints ready

The platform

From scattered documents to controlled regulatory operations.

Regulatory work rarely fails because one document is missing. It fails when decisions, evidence, and ownership drift apart. ReguLabs keeps those relationships visible through the full device lifecycle.

A

Build the technical file

Move from classification and GSPR through risk, clinical evaluation, UDI, and post-market planning in a guided device workspace.

  • Structured Annex II/III content
  • Controlled revisions and exports
B

Keep evidence connected

Trace requirements to risks, controls, verification files, and clinical claims without rebuilding the chain before every review.

  • Fingerprint evidence on upload
  • Queryable traceability graph
C

Make review accountable

Separate authoring, review, and approval. Preserve findings, rationales, signatures, and state changes in an auditable record.

  • Role-based responsibilities
  • Hash-chained audit history

One device. One evidence chain.

A submission spine your whole team can follow.

Every stage remains connected to the same device record. Gaps surface where the work happens, not at the end of a document scramble.

  1. 01ClassificationRule and rationale
  2. 02GSPRApplicable requirements
  3. 03RiskControls and benefit-risk
  4. 04Technical fileControlled content
  5. 05ClinicalClaims and evidence
  6. 06UDIOperator readiness
  7. 07PMSSignals and vigilance
  8. 08PSURLifecycle reporting

Designed for controlled work

Assistance without the black box.

01

AI proposes. People decide.

Suggestions remain drafts until an accountable person reviews and records the decision.

02

Evidence remains inspectable.

Source links, fingerprints, versions, and relationships stay available for review.

03

Readiness is a test, not a feeling.

Submission checks surface missing approvals, broken links, and unresolved work before release.

ReguLabs workspace

Keep the thread intact.

Continue to the secure MDR workspace to manage your devices, evidence, reviews, and submission packages.

Open secure workspace