Strategic Business Advisory for European Market

With over 15 years of experience in China-Europe business operations and regulatory compliance, Brosper excels in providing expert guidance for companies seeking to expand into the European market. We specialize in helping businesses navigate the complexities of European regulations, with a particular focus on medical device compliance management, CE certification, and medical device registration, ensuring compliance with the EU Medical Device Regulation (MDR) 2017/745, the EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and the EUDAMED system for registration and post-market surveillance.

Our Services Include:

• CE certification and medical device registration in compliance with the EU Medical Device Regulation (MDR) 2017/745, the EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and the EUDAMED system, etc.
• Support for regulatory approvals and the preparation of necessary documentation
• EU Market entry strategies tailored to meet specific regulatory requirements for medical devices
• Ongoing operation and compliance support to ensure continued regulatory adherence post-market