VitaRegX
Book a demo
Platform

One regulatory file, four modules.

Each module produces audit-ready, citation-traceable outputs and stops short of decisions only a qualified RA, QA, or clinical reviewer can sign off. The four sit under one technical file so claims, evidence, and lifecycle updates stay synchronised.

Book a demoHow it works
The four modules

Deep-dive into each module.

01

Gap Scout

Dual-track classification for EU MDR 2017/745 and UK MDR 2002. Maps applicable GSPRs and Essential Requirements. Flags evidence gaps before submission.

Outputs

  • Regime determination — medical device under MDR vs biocidal product under BPR (boundary call)
  • Dual-track classification with explicit upgrade-risk flagging (EU MDR Rule 11 / Rule 14, UK MDR reg. 7)
  • GSPR / ER applicability map (EU MDR Annex I, UK MDR Schedule 2A)
  • Evidence gap list, ordered by impact on submission readiness

Not for

Final classification decisions — a qualified RA professional signs off.

EU MDR 2017/745 Annex VIII Rule 11 · EU BPR 528/2012 Article 95
02

Dossier Architect

Drafts technical documentation aligned to EU MDR Annex II / III. Every assertion links to its source — test report, risk file, clinical reference, or regulation.

Outputs

  • Draft technical documentation, structured to EU MDR Annex II / III
  • Claim-to-evidence trace — every assertion has a source link
  • Inline change tracking with editor, approver, and rationale
  • Export to PDF and structured XML for submission packaging

Not for

Replacing the technical author's judgement. Drafts are review inputs, not final files.

EU MDR 2017/745 Annex II, Section 6.1 · ISO 13485 §7.5
03

Clinical Synthesizer

Structures clinical evaluation: state-of-the-art review, equivalent device search, evidence indexing, and CER section drafts. Human review required before sign-off.

Outputs

  • State-of-the-art review structure
  • Equivalent device candidates from EUDAMED and FDA MAUDE metadata
  • CER section drafts with literature reference indices
  • Gap log between claim set and clinical evidence

Not for

Producing a final CER. Clinical evaluation requires qualified clinician review.

MDCG 2020-13 · MEDDEV 2.7/1 rev. 4
04

Watchtower

Monitors MHRA CAS, FDA MAUDE, EUDAMED vigilance, and Field Safety Notices. Flags signal candidates and prompts PMS / PSUR updates.

Outputs

  • Signal candidates from MHRA CAS, FDA MAUDE, EUDAMED, and FSNs
  • ECHA Article 95 list changes for active-substance products
  • Suggested PSUR / PMS update items, with reasoning trail
  • Recertification-readiness checklist updated continuously

Not for

Filing vigilance reports on the manufacturer's behalf.

EU MDR 2017/745 Articles 83–86 · UK MDR 2002 (SI 2024/1368) reg. 44ZM
How it works

From intake to post-market surveillance, in one traceable file.

  1. 01

    Intake

    Device or product description, intended purpose, target markets, active substances.

  2. 02

    Boundary

    Determine the regime: medical device under EU MDR 2017/745 vs biocidal product under EU BPR 528/2012.

  3. 03

    Classify

    Apply EU MDR and UK MDR 2002 rules, or BPR active-substance and product-type analysis.

  4. 04

    Map

    Applicable GSPRs and Essential Requirements identified; evidence gaps surfaced before they become reviewer findings.

  5. 05

    Draft

    Technical documentation generated with citation traceability back to source — every assertion linked.

  6. 06

    Review & Monitor

    Human approval, followed by continuous PMS or post-authorisation monitoring throughout the product lifecycle.

Built for regulated workflows

AI you can defend in a Notified Body audit.

Cited sources

Every regulatory assertion links to the article, annex, or guidance section it draws from.

Human-in-the-loop

High-stakes outputs require sign-off by a qualified RA / QA reviewer before they leave the platform.

Audit trail

Every draft, edit, citation, and approval is recorded and exportable as a regulatory record.

No training on customer data

Your regulatory files are never used to train shared models.

Integrations

Fits the file you already keep.

VitaRegX connects to the document stores and quality systems most MedTech teams already use — SharePoint, Google Drive, Azure Blob, and ISO 13485-aligned eQMS platforms — and exports to PDF and structured XML for submission packaging. Available integrations expand on a published roadmap; bespoke connectors are scoped on request.

See VitaRegX on your device.

Send us your intended purpose and target markets. We'll show you a sample classification and traceability output in 30 minutes.

Book a demoJoin early access