Normiq
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From classification to reimbursement, the roadmap for your medical devices

Class, target market, and Normiq generates the full pathway: steps sourced from the regulations, estimated durations, known pitfalls, documents to produce. For founders, regulatory affairs leads and consultants who carry the file.

7-day free trial · No credit card · Cancel anytime

29 regulatory pathways, Europe, Switzerland and the United States
342 documented steps in four languages
🇪🇺 + 🇨🇭 EU & CH Compliance

The whole pathway, in one tool

Every function reads the same product record: what you enter once is used everywhere.

Your roadmap in 30 seconds

MDR/IVDR class, target market: the full CE and Swissmedic pathway, step by step, with estimated durations and applicable articles.

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Expertise at every step

Best practices, common mistakes, MDCG guidance and applicable standards — shown at the step where they matter, in four languages.

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All the way to reimbursement

Certified is not reimbursed. Normiq guides the Swiss (LiMA, SwissDRG), French (HAS, LPPR, CCAM) and German (DiGA, Hilfsmittel) pathways.

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Which market first

Market access country by country based on your progress, and AI-estimated market size — to choose where to invest before spending.

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Your documents, pre-drafted

Technical documentation, clinical evaluation, risk management plan: drafts generated from your product record, for the responsible person to review.

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What your file is missing

Upload your existing PDFs: the AI checks them against MDR/IVDR requirements and ranks the gaps by severity, with the article alongside.

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The right notified body

Regulation, class, scope of designation, languages: Normiq shortlists the notified bodies that match your device.

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One file, one team, one history

One dashboard per product. Invite your team, your consultant or your auditor with distinct rights; every action is time-stamped.

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Who it is for

Three ways of carrying a regulatory file. One tool.

The founder without a regulatory team

You know what your device does, not yet what the regulation expects of it. The roadmap tells you what to do, in which order, and why.

The in-house regulatory affairs lead

You know the regulation; what is missing is time. Normiq keeps the file up to date, follows the team and prepares the documents so that you correct them rather than write them.

The regulatory affairs consultant

You follow several clients at once. One product per file, a sourced roadmap you do not rebuild for every engagement, and access to give each client with the right role.

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. The US market has its own access status, tracked separately.

Transparent and simple pricing

Choose the plan that matches the size of your medical device portfolio.

7 days free

Starter

For MedTech startups launching their first device

500CHF / month
  • 2 products maximum
  • 2 team members
  • Personalised MDR/IVDR regulatory roadmap
  • 3 AI-generated regulatory documents
  • Automatic non-conformity detection
  • Reimbursement pathways (CH, FR, DE)
  • AI market analysis
  • EUDAMED notified bodies database access
  • Email support
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Scale

For RA teams with a growing product portfolio

2 000CHF / month
  • 20 products maximum
  • Everything in Starter +
  • Unlimited AI documents
  • Unlimited team members
  • Centralised multi-product management
  • Dedicated priority support
  • Guided onboarding

Enterprise

For organisations with complex needs and a large portfolio

Custom
  • Unlimited products
  • Everything in Scale +
  • Dedicated regulatory support
  • RA team training
  • Dedicated SLA and environment
  • Custom integrations

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.

Regulatory support for medical devices covers all services helping manufacturers navigate MDR 2017/745 and IVDR 2017/746 requirements: technical documentation, clinical evaluation, notified body selection, CE marking preparation, and market access strategy for Europe and Switzerland. Normiq structures these processes into one roadmap per device, without replacing a notified body's assessment.

Normiq analyses your medical device classification (Class I, IIa, IIb, III or IVD), your target market and technical characteristics to recommend the most suitable notified bodies. We compare timelines, costs, specialisations and availability of notified bodies designated under MDR 2017/745 and IVDR 2017/746.

A notified body is a conformity assessment body designated by an EU member state to evaluate medical devices before they are placed on the market. For Class IIa, IIb, III devices (MDR) and Class B, C, D (IVDR), involvement of a notified body is mandatory to obtain CE marking. Normiq guides you through the selection process and dossier preparation.

Normiq accelerates your MDR market entry by automating your certification roadmap creation, proactively detecting non-conformities in your technical documentation, and guiding you step by step towards CE marking. Our AI analyses your file and identifies gaps before the notified body finds them, reducing back-and-forth and delays.

Yes, Normiq supports all medical devices (Classes I, IIa, IIb, III) under MDR 2017/745, all in vitro diagnostics (Classes A, B, C, D) under IVDR 2017/746, as well as pharmaceutical products. Our platform automatically adapts to the specific regulatory requirements of your product category and target market.

No, Normiq is a regulatory compliance support tool that complements the work of your consultants and notified bodies. The platform optimally prepares you upfront: certification roadmap, document management, non-conformity detection. This significantly reduces the time and costs of MDR/IVDR certification.

Normiq integrates Swiss market-specific requirements: Swissmedic notification for Class IIb and III devices, ODim requirements (Medical Devices Ordinance), authorised representative in Switzerland, and reimbursement pathways (LiMA, SwissDRG). The platform guides you on the key differences between EU and CH regulatory pathways.

Absolutely. All your data is encrypted in transit (TLS 1.3) and at rest (AES-256). Our database is hosted in Switzerland, in Zurich, and we comply with the GDPR and the Swiss FADP. Your technical documents and product information are never shared with third parties.

No. Normiq covers the European Union (MDR 2017/745, IVDR 2017/746), Switzerland (MedDO, TPA, Swissmedic) and the United States (21 CFR, FDA): classification, establishment registration and US agent, QMSR, 510(k), De Novo, PMA, labelling and unique device identification, vigilance. Canada (Health Canada) and the United Kingdom (UKCA/MHRA) remain under consideration, with no announced date.

Have more questions? Contact our team