For medical devices, IVDs and Software as a Medical Device (SaMD) — across EU MDR, IVDR, UK MDR and FDA.
Stop wrestling with eQMS tools built for the last decade. Syntax Regulatory was built for this one — affordable, intelligent and built for continuous compliance.
Document control, design control, risk, CAPA, audit and training — built for medical devices, IVDs and SaMD, and designed for continuous compliance.
Design Control for any device — from the simple to the most complex. Master traceability where every requirement is connected, every risk mitigated and verified. Your Design and Development File is auto-assembled from your controlled records as you work — audit-ready, not pulled together in a panic.
Explore design controlThe first eQMS with native post-market performance monitoring for AI/ML algorithms. Your production system streams performance metrics automatically; DriftGuard watches against Advisory, Warning and Critical thresholds and raises a pre-populated NC/CAPA the moment one is breached — with an immutable, hash-chained audit trail. Built for EU MDR Article 83, UK MDR Regulation 19 and the EU AI Act.
Explore DriftGuardBuilt for engineers and scientists who struggle with regulatory writing — 16 years of quality and regulatory engineering expertise, encoded. Your team drafts faster and more consistently, so by the time a document reaches the wider team it is in good shape: coherent, consistent and ready for meaningful review, not rescue. It moves you from building to submission — it does not replace your QA team.
See how it worksBuilt by someone who has used eQMS tools every day for 16 years across J&J, Siemens Healthineers, Viatris and more. Simple, practical and consistent — whether you are a one-person QA function or a cross-functional department. No bloat, no year-three pricing shock.
Meet the founderValidation is usually months of effort or thousands in consultant fees. We take that weight off you: Syntax Regulatory is validated by us, and we give you a complete IQ, OQ and PQ protocol package to confirm it in your own environment. You stay in control of your regulatory responsibility — we just make it fast and free.
No extra cost · no consultant required · no implementation fee
| Feature | Syntax Regulatory | Legacy eQMS |
|---|---|---|
| Native AI algorithm monitoring | DriftGuard — built in | Not available |
| AI-assisted regulatory authoring | Included | Rarely |
| Validation | Validated by us + free IQ/OQ/PQ package | Costly internal effort or consultant fees |
| Implementation fee | None | Often thousands |
| Pricing | Simple & transparent, from £299 | Per-user fees that grow with you |
| Free trial | 3 months · no card | Limited or none |
| Scope | Medical devices · IVDs · SaMD | Generic, one-size-fits-all |
Transparent pricing from £299/month to custom enterprise. No hidden costs, no implementation fees, no consultant needed to get started. Three months free at launch.
From £299/month for up to 15 users, scaling to custom Enterprise. Three months free, no surprises, no per-user creep.
Native AI algorithm performance monitoring, added per algorithm above your tier limit. Post-market surveillance, built in.
A free tier forever, plus an affordable upgrade for heavier use. Free across all tiers for the first nine months after launch.
When you need a human, expert quality and regulatory support is available at competitive rates — never required, always there.
See it in action
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