European Union
The European Union medical device market, serving over 500 million patients, offers vast opportunities but requires strict compliance with Regulation (EU) 2017/745 (MDR).
Select your region
Our international standing means we offer medical device and IVD regulatory compliance services across every major global market. From EU MDR and IVDR to FDA, UK MDR, Health Canada, and Swiss MedDO – we are an ideal partner for manufacturers who need consistent, reliable compliance support across multiple territories at once.
Global Medical Device Compliance – Beyond Borders
At Obelis, our commitment to supporting your compliance journey does not stop at our core territories. Through our trusted global network of partners across Asia, South America, Africa, and the Middle East, we help medical device and IVD manufacturers enter new markets with the same confidence and expertise we bring to every region we serve.
Whether you are preparing a first launch in an emerging market or expanding an established global portfolio, our partners on the ground ensure your products meet local regulatory requirements – from device registration and technical documentation to authorized representative appointment and post-market surveillance obligations.
