Regulatory Consulting for Medical Devices & IVDs

MDSS USA LLC

Chicago, IL, United States

With over 30 years of experience, MDSS is a leading Authorized Representative and Regulatory Consulting organization, headquartered in Germany with offices in the United States, the United Kingdom, Switzerland, and Australia. Our services include: European Authorized Representative (EC REP) UK Responsible Person (UKRP) Swiss Authorized Representative (CH-REP) U.S. Agent Australian Sponsor Other services (e.g. Free Sales Certificates, GDPR, GPSR, Representative for Clinical Investigations, Vigilance, …) In addition to providing In-Country Representation services — helping streamline global market access through a single, reliable partner, so you can focus on your core business and innovation — we offer regulatory strategy consulting for medical devices and IVDs, support with pre-submissions and marketing authorization applications to the FDA , and assistance with EU MDR and EU IVDR compliance. Why MDSS? 30+ years of regulatory expertise Same trusted address for 20+ years Personalized support and tailored approach that sets MDSS apart from other regulatory service providers Collaborative network of offices spanning from the USA to Australia – single verification that grants access to three key markets: the EU, the UK, and Switzerland Independent services that protect your intellectual property Full control of your technical product files—no need to share with local importers or distributors MDSS is a member of the European Association of Authorized Representatives ( EAAR ), the UK Responsible Person Association ( UKRPA ), Swiss Medtech and the Medical Technology Association of Australia ( MTAA ).