Gap analysis
Structured review of existing documentation against EU MDR 2017/745 and UK MDR 2002 requirements; evidence gaps surfaced before they become reviewer findings.
About
Regulatory technology built by people who understand what reviewers expect.
VitaRegX is a UK-registered regulatory technology company. We help Regulatory Affairs and Quality teams at MedTech manufacturers produce traceable, review-ready documentation across EU MDR 2017/745 and UK MDR 2002 (SI 2024/1368).
Mission
Make regulatory work defensible by construction.
Regulatory teams shouldn't have to rebuild their citation trail every time a reviewer asks a question. We're building the platform that keeps the file in a state where the answer is always one click away.
Every output VitaRegX produces is decision-support — drafts, classifications, gap lists, monitoring signals — and stops short of any decision that requires a qualified RA, QA, or clinical reviewer's signature. We don't act as legal representative, UK Responsible Person, or substitute for a Notified Body conformity assessment.
Methodology
How a file becomes review-ready.
Structured drafting
Technical files, GSPR mapping, and claim-to-evidence traceability with full change history and reviewer-friendly layout.
Reviewer readiness
Final cross-checks against MDCG and MHRA expectations, with citation trails ready for Notified Body review.
Lifecycle maintenance
After submission, the file keeps moving — PMS, PSUR, vigilance signals, and recertification all run from the same evidence graph.
Who we work with
Built for the teams that own the file.
Regulatory Affairs leads
Class IIa and IIb manufacturers running dual EU MDR / UK MDR documentation.
Quality Assurance leads
ISO 13485 quality systems where citation traceability and audit trails are non-negotiable.
Clinical evaluation teams
CER authoring with state-of-the-art reviews and equivalent device searches across EUDAMED and FDA MAUDE.
Post-market surveillance
Monitoring MHRA CAS, EUDAMED vigilance, and FSNs into a single signal queue with reasoning trails.
Values
Five anchors we don't negotiate.
Traceability
Every assertion links to its source. No paraphrased regulations, no orphaned claims, no implicit evidence.
Transparency
Full change history. Recorded drafts. Citations a reviewer can verify against the consolidated regulation text.
Lifecycle thinking
The regulatory file is never finished. We design for recertification, PMS, and post-authorisation monitoring from day one.
Conservative claims
We say readiness, not approval. We never claim to substitute for a Notified Body, UK Approved Body, or HSE conformity assessment.
Cite the source
Regulation names are spelled exactly as they appear in the consolidated text. No vendor paraphrase, no marketing rewording.
Team
Regulatory practitioners and engineers.
VitaRegX is built by regulatory practitioners and engineers with direct MedTech and Notified Body experience.
Company
VitaRegX LimitedLong Ditton, Surbiton, England, KT6 5JY, United KingdomCompanies House: 16899467ICO registration: {ICO_TBD}Registered details.
VitaRegX is decision-support software. It is not itself a medical device, not Software as a Medical Device (SaMD), and not a substitute for a Notified Body, UK Approved Body, or HSE conformity assessment.
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.