Medical device market access, engineered for five jurisdictions.
Amstermed is a specialist regulatory consultancy acting as EC-REP, UKRP, CH-REP, Australian Sponsor and US Agent — supported by in-house technical writers, clinical evaluators and quality engineers.
About Amstermed
Precision-Driven Regulatory Navigation
Founded in Amsterdam, Amstermed has grown into a trusted global partner for medical device manufacturers seeking market access across the world’s most demanding regulatory environments.
Our multidisciplinary team combines deep technical knowledge with regulatory strategy, ensuring every submission meets the highest standards of compliance. We don’t just process paperwork — we architect pathways to approval.
Our Services
Comprehensive Regulatory Services
End-to-end regulatory support across five major healthcare markets. Each service is tailored to the specific requirements of its jurisdiction.
EU Authorised Representative
Your regulatory presence in the European Union under MDR 2017/745 and IVDR 2017/746.
UK Responsible Person (UKRP)
MHRA-registered UKRP services for Great Britain market access under UK MDR 2002.
Swiss Authorised Representative (CH-REP)
Swissmedic-recognised CH-REP for the Swiss medical device market under MedDO.
Featured Expertise
Deep Technical Knowledge Across Every Stage of Compliance
Our regulatory specialists provide expert guidance throughout the medical device lifecycle, supporting manufacturers with technical documentation, regulatory strategy, and market access across multiple international jurisdictions.
Our Process
A Clear Path to Market Access
Our standardized four-step process transforms complexity into a structured, transparent journey from concept to compliance.
01
Assessment & Regulatory Strategy
We evaluate your medical device, determine its regulatory classification, and develop the most appropriate compliance and market access strategy for your target regions.
02
Documentation & Regulatory Submission
We prepare and review technical documentation, clinical evaluations, and regulatory submissions, while managing communication with the relevant authorities throughout the review process.
03
Market Approval & Ongoing Compliance
From regulatory approval to post-market obligations, we support ongoing vigilance, compliance maintenance, and regulatory updates to help keep your products on the market.
Who We Are?
Your Trusted Global Partner for Medical Device Regulatory Compliance
Amstermed is a trusted Authorized Representative providing comprehensive regulatory support for Medical Devices and In Vitro Diagnostic Devices across major international markets. Acting as your legal representative, we serve as the essential link between manufacturers and regulatory authorities throughout the European Union, the United Kingdom, Switzerland, Australia, and the United States, ensuring every stage of the compliance process is managed with precision and professionalism.
Ready to Navigate Global Regulatory Requirements?
Ready to Navigate Global Regulatory Requirements?
Whether you’re preparing for market entry or maintaining ongoing compliance, our regulatory specialists are here to guide you through every stage with clarity, precision, and confidence.