Simplifying compliance for medical devices
At Normiq, we believe medical innovation should not be slowed down by regulatory complexity. Our mission is to democratise market access for medical devices in Europe and beyond.
Our Mission
Make regulatory compliance accessible, fast and intelligent for all companies in the medical sector, from startups to large groups. We transform a complex and time-consuming process into a smooth and guided experience.
Our Vision
Become the global reference platform for regulatory management of medical devices. We want to enable every medical innovation to reach the patients who need it, without unnecessary administrative barriers.
Why does Normiq exist?
The medical device sector faces increasingly strict and complex regulation. The MDR 2017/745 and IVDR 2017/746 regulations have significantly increased compliance requirements, forcing manufacturers to navigate a maze of standards, documentation and certification processes.
The result? Longer time-to-market, exploding regulatory costs, and many innovations that never reach patients.
Normiq was created to change that. By combining artificial intelligence, automation and regulatory expertise, we reduce by an average of 40% the time needed to obtain certification, while ensuring full compliance.
Our Values
Compliance
We guarantee the accuracy of our regulatory analyses and the rigour of our processes. Your total compliance is our absolute commitment.
Security
Protecting your sensitive data is our priority. Encryption, strict isolation and GDPR/LPD compliance ensure complete confidentiality of your information.
Solidarity
We serve all companies, startups or large groups, with the same excellence. Every medical innovation deserves to reach the patients who need it.
What's ahead
March - May 2026 â Beta testing period
Validation phase with early customers. MDR/IVDR compliance for the EU and Swissmedic regulation for Switzerland. AI-powered automatic non-conformity detection system.
Late May 2026 â Official launch
Public opening of the Normiq platform. Full access to compliance management features, certification roadmap, and AI-powered market analyses.
Q3-Q4 2026 â Reimbursement pathways
Complete roadmap for obtaining reimbursement from health insurers in France (HAS/RIAP), Germany (GKV/IQWiG) and Switzerland (LaMal/TARMED).
2027 â International expansion
FDA compliance for the United States. Expansion into Asian and Latin American markets.
Partner Network
Normiq supports you in your compliance journey, but some situations require the expertise of specialised professionals. We can recommend trusted partners.
Specialised Law Firms
Need in-depth legal support? We can connect you with law firms specialised in health law and medical device regulation (EU, Switzerland, US).
Regulatory Affairs Consultants
For tailored operational support: technical file drafting, certification, quality audits. We collaborate with independent experts and notified bodies.
Interested in these services? Contact us at contact@normiq.app