Regulatory support for your medical devices
Normiq structures and accelerates your regulatory journey: target market analysis, notified body matching, AI-drafted documents and orientation towards the most profitable opportunities. A decision-support tool that complements your Regulatory Affairs team — not a substitute for assessment by a notified body.
7-day free trial · No credit card · Cancel anytime
Less time on regulations, more time on the market
Normiq turns your regulatory compliance into a competitive advantage — so you reach the right markets before your competitors.
Automatically generated roadmap
Enter your product details, get a complete certification roadmap in 30 seconds, tailored to your MDR/IVDR class and target market.
The right market, at the right time
EU, Switzerland, France, Germany — Normiq analyses the regulatory constraints of each market and tells you which one to tackle first to maximise your ROI.
Time-to-Market cut in half
No more months wasted discovering gaps at submission time. Normiq identifies blockers early and guides you to fix them.
Your technical file, written by AI
Technical Notice, Clinical Evaluation, Risk Management Plan — Normiq generates pre-filled drafts to be reviewed and validated by your Regulatory Affairs lead. Never face a blank page again.
Reimbursement: unlock new revenue streams
The only platform that guides you through LaMal (CH), HAS/RIAP (FR) and GKV (DE) pathways — so your device gets reimbursed, not just certified.
Estimate your market before investing
Before launching a €200k MDR certification, know if the market is worth it. AI estimates your addressable market by country.
Anticipate regulatory blockers
Normiq automatically detects inconsistencies in your file and flags them before submission — so you approach each step with a solid dossier.
Everything in one place
Roadmap, compliance, documents, reimbursement, notified bodies, market analysis — all in one platform. No more 10 disparate tools.
EUDAMED Readiness Check
Assess your preparation for the EUDAMED mandate in 60 seconds. Personalized score, recommendations and action plan — free.
600+ tips and embedded guidance
At every step of the roadmap: do's and don'ts, common pitfalls, official references and best practices. The equivalent of 30 days of consulting, built right into the tool.
Product-by-product view
Each product has its own dashboard: regulatory progress, market access, roadmap, reimbursement. Compare and prioritize at a glance.
Certification cost & timeline estimator
How much will it cost? How long will it take? Normiq aggregates durations and costs from every phase of your roadmap into a clear total — the answer your consultant charges EUR 2,000/day for.
Assign roadmap steps to your team
Assign every roadmap step to a team member. Everyone sees their tasks, everyone sees overall progress — Normiq becomes your regulatory backlog.
Board & investor report in 1 click
Generate a branded PDF in one click: regulatory progress, budget spent, upcoming milestones and risks. No more 4 hours of slides the night before the board.
Why medtech founders choose Normiq
Not another compliance tool — the GPS between your prototype and your first sale, from CE marking all the way to reimbursement.
EUDAMED is becoming mandatory. Is your dossier ready?
On May 28, 2026, EUDAMED registration becomes mandatory to place your devices on the EU market. Without SRN, UDI-DI and actor registration, your sales stop. Normiq tracks every step, every deadline, every required document.
Time left before EUDAMED enforcement
May 28, 2026 — 00:00 UTC
30 days of consulting, pre-built into your roadmap
Class I, IIa, IIb, III, IVD A-D, Pharma: Normiq delivers a roadmap of 50 to 220 sub-steps, sourced from the official texts, with estimated durations, classic pitfalls and embedded guidance. What a consultant bills EUR 15,000 to draft.
CE + Swissmedic + CH/FR/DE reimbursement, in one dashboard
Other tools stop at QMS. Normiq takes you all the way to reimbursement: LIMA and SwissDRG in Switzerland, LPPR and CCAM in France, Hilfsmittel and DiGA in Germany. No more three national consultants in parallel.
A native audit trail, exportable in one click
Every checked box, every uploaded document, every status change is timestamped and traced. The day your Notified Body, ANSM or Swissmedic audits you, your dossier is ready — no digging through Google Drive.
Upload your PDFs — the AI tells you what's missing
Technical file, clinical evaluation, risk management plan: Normiq reads your existing documents and flags potential gaps against MDR/IVDR to guide your internal review. Final assessment remains the responsibility of your Regulatory Affairs team.
EUDAMED Readiness Check
Are you ready for May 28? Results in 60 seconds.
Identify the markets most accessible and most impactful
Normiq automatically analyses which European and Swiss markets are accessible based on your certifications, and evaluates the commercial potential of each.
Chargement de la carte...
Allemagne
Avancement
France
Avancement
Suisse
Avancement
Italie
Avancement
Exemple d'analyse IA pour un dispositif médical Classe IIa
Transparent and simple pricing
Choose the plan that matches the size of your medical device portfolio.
Starter
For MedTech startups launching their first device
All plans include a 7-day free trial, no credit card required.
Questions? Need a custom quote? Contact our team
Frequently asked questions
Everything you need to know about Normiq and regulatory compliance.
Have more questions? Contact our team