NordMDR AB was founded with one purpose: to make EU regulatory compliance straightforward, predictable and affordable for manufacturers who cannot afford the fees of large consulting firms — and do not want to hand their account to a junior consultant.
20 years of hands-on regulatory experience spans the full spectrum of EU medical device compliance — from initial classification through to post-market surveillance and everything in between.
Full EU MDR compliance including technical documentation preparation, Annex II and III requirements, clinical evaluation and conformity assessment for all device classes.
In vitro diagnostic regulation compliance, performance evaluation plans, classification under the new four-tier system, and EUDAMED IVD registration.
Complete actor registration, SRN acquisition, device linkage and ongoing EUDAMED maintenance for manufacturers and EU Authorised Representatives.
Electromagnetic compatibility compliance, EMC testing support, technical file preparation and CE marking across all product categories for the EU and UK markets.
ISO 26262 automotive functional safety, IEC 61508 industrial safety, safety case development, FMEA and hazard analysis for safety-critical embedded systems.
Quality management system development, ISO 13485 gap analysis, audit preparation and post-market surveillance system design under EU MDR Articles 83–86.
At NordMDR AB there are no account managers, no handoffs and no junior consultants. Every engagement is handled directly by Nani — 20 years of regulatory experience on every call, every email, every deliverable.
Every engagement is quoted at a fixed price before we start. No hourly billing, no scope creep, no invoices that are three times what you expected. You know the cost before you commit.
NordMDR AB is a Swedish registered company (AB). This gives us full EU legal standing as an Authorised Representative under EU MDR Article 11 — a requirement that offshore or non-EU firms cannot meet.
We understand that regulatory deadlines do not wait. Once you decide to proceed, we complete EU AR appointment and EUDAMED registration initiation within 5 business days — not weeks.
Most MDR consultants cover only medical devices. Our expertise spans EU MDR, IVDR, EMC compliance, functional safety and Swiss MedDO — making us a genuine one-stop regulatory partner for complex product portfolios.
NordMDR AB carries professional indemnity insurance appropriate to the scope of EU Authorised Representative and regulatory consulting services — giving manufacturers the protection they need from a compliant partner.
EU MDR places significant legal obligations on Authorised Representatives. We take those obligations seriously and have the qualifications and legal structure to meet them.
Registered EU AR under EU MDR 2017/745 Article 11 and IVDR 2017/746. Swedish AB company with full EU legal standing to act as AR for non-EU manufacturers across all 27 member states.
Over two decades of hands-on experience in medtech regulatory affairs covering EU MDR, IVDR, EMC, functional safety and quality management systems across multiple device classes and industries.
Qualified to serve as Person Responsible for Regulatory Compliance under EU MDR Article 15, with the educational background and professional experience required by the regulation.
NordMDR AB carries professional indemnity insurance appropriate to EU AR and regulatory consulting services — protecting our clients and demonstrating our commitment to professional accountability.
We tell you exactly what you need — not what generates the most billable hours. If something is not needed, we say so.
Every assessment, every gap analysis, every recommendation is delivered in writing. No verbal-only advice that you cannot act on or verify.
Regulatory deadlines are fixed. We build our work around your timeline and deliver on time — every time.
Book a free 20-minute call. We will give you a straight assessment of what you need and what it will cost — no sales pitch, no obligation.
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