We build EU/UK compliant technical files and provide expert regulatory guidance.
Experts in setting up, maintaining, and stress-testing quality systems.
EU Authorised Representative
Your reliable regulatory partner in the European Union. [EC-REP]
We help importers meet their complex regulatory obligations.
Experts in EUDAMED Actor and UDI-DI registrations.
Our expert team delivers training on various regulatory and quality topics.
- About Us
Manufacturers of medical devices looking to sell their products in the European Union (EU) will need to understand and comply with the regulatory requirements of