Your EU, UK & US local medical device representative
Medical device and IVD regulations often require local presence to place products on respective market. With offices in the EU, UK, and US, Lea Reg acts as your designated local representative or agent, and assist medical device companies to meet the regulatory requirements.
All our services are performed according to our ISO 13485 certified quality management system.
Together with our partner companies, Clarvin, Devicia, Limulus Bio and Kickfile, we support the entire compliance process – from early pre-clinical development to Post production phase and distribution.
FROM US / UK EU
EU authorized representative
Medical device manufacturers located outside the European Union must assign an EU Authorized Representative that is based within the EU to place a medical device on the EU market. Lea Reg support non-EU based medical device and IVD companies by designating Lea Reg as
Authorised Representative within the EU in accordance with EU Regulations (EU) 2017/745 (MDR) & (EU) 2017/746 (IVDR). Lea Reg has an ISO 13485 certified Quality Management System which ensures that our services are compliant with the Economic Operator’s obligations as specified in the MDR and IVDR.
FROM US / EU UK
UK Responsible Person
FROM US / UK EU
FROM EU UK / US
FROM EU / UK US
As your local partner we support medical device and IVD companies to get global market access.
The conference will bring people together to inspire, educate and network May 4-5 2022 in Copenhagen, Denmark. Register your contact information at the conference page to stay tuned for more information, see you in Copenhagen!
The conference will bring people together to inspire, educate and network May 4-5 2022 in Copenhagen, Denmark.
Register your contact information at the conference page to stay tuned for more information, see you in Copenhagen!
Our ecosystem for full-service medical device compliance
Together with Devicia, Limulus Bio, Clarvin and Kickfile, we support all your needs, everywhere, every time. Irrespective if it relates to strategy, Quality Assurance, Regulatory Affairs, Clinical Affairs, Biocompatibility, UK representation or EU Authorized Representative.