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
Controlled MDR work for EU device teams
Build, review, and maintain your MDR evidence in one controlled workspace.
Link requirements, risks, verification evidence, clinical claims, and post-market work to each device. See what is complete, what is missing, and who is accountable before a review or release.
Human decisions stay accountable. AI assistance stays cited and reviewable. See the evidence chain ↓
Workspace access is provisioned by your organization administrator.
Illustrative device evidence chain
Reviewable
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01
RequirementGSPR 10.1Linked
Chemical and physical properties
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02
Risk controlRC-014Verified
Material specification and verification
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03
EvidenceEV-028In review
Biocompatibility test report
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04
Controlled decisionPRRC sign-offPending
Release with accountable approval
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 device lifecycle and gives each person a clear next action.
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
Make responsibility visible
Separate administration, authoring, review, and PRRC approval. Preserve findings, rationales, signatures, and state changes in a controlled record.
- Author, Reviewer, and PRRC capacities
- Hash-chained audit history
Clear ownership
Administration and dossier authorship are different jobs.
A well-controlled workspace makes the distinction visible. The person who manages access does not automatically become the person who writes or approves the technical documentation.
Tenant administrator
Provisions accounts, assigns capacities, configures workflow policies, and keeps the workspace operating.
Manages access — not automatic dossier approval.
Author
Builds the device record, drafts evidence, records rationale, and responds to review findings.
Creates the controlled working record.
Reviewer
Checks completeness, consistency, traceability, and the evidence behind the proposed decision.
Provides an independent review where required.
PRRC
Acts in the accountable regulatory capacity, verifies qualification, and makes the approval decision.
The platform records the decision; it does not make it.
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.
- 01ClassificationRule and rationale
- 02GSPRApplicable requirements
- 03RiskControls and benefit-risk
- 04Technical fileControlled content
- 05ClinicalClaims and evidence
- 06UDIOperator readiness
- 07PMSSignals and vigilance
- 08PSURLifecycle reporting
Structured decisions
Classification is reviewable, not a black box.
ReguLabs uses a structured, deterministic flow to record the applicable MDR rule, device class, rationale, alternatives considered, and supporting evidence.
AI may help draft. An accountable person reviews the reasoning and records the final classification decision.
Designed for controlled work
Assistance without the black box.
AI assists; people decide.
Suggestions remain drafts until an accountable person reviews and records the decision.
Evidence remains inspectable.
Source links, fingerprints, versions, and relationships stay available for review.
Readiness shows what is missing.
Checks surface missing fields, approvals, broken links, and unresolved work before release. They do not guarantee conformity or certification.
Use it with the right expectations
ReguLabs controls the work. Your experts remain responsible.
What ReguLabs does
- Organizes MDR evidence around each device.
- Connects requirements, risks, evidence, claims, and decisions.
- Controls revisions, responsibilities, reviews, and approvals.
- Shows readiness gaps before a submission or release.
What it does not do
- Replace the manufacturer, PRRC, consultant, notified body, or competent authority.
- Make the final regulatory or conformity decision.
- Guarantee certification, approval, or a successful audit.
- Turn incomplete or demonstration evidence into conformity.
See it on your device
Bring one real evidence chain to a walkthrough.
We will show how a device moves from classification and GSPR through risk, technical documentation, review, PRRC approval, and post-market work.
Workspace accounts are provisioned by an administrator. ReguLabs helps control the evidence and workflow; it does not replace professional regulatory responsibility.