We will be your PRRC or EU AR under the new EU Medical Device and In-Vitro Diagnostic Regulations.
We can help you successfully CE Mark your device under the Medical Device Regulation and In-Vitro Diagnostic Regulation
We can be your guide for clearance/ approval of your device in the US under the 510k, PMA or De Novo routes.
Review and approval of all elements of Medical Device and IVD submission data (CE mark & US FDA) including the following:
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
AI is transforming the healthcare sector in many ways, from improving diagnosis and treatment to providing personalised care and support.
The EU MDR extension for certain medical devices only allows you up until 31st December 2027 or 2028 if you have a signed contract..
Prioritise patient safety with these steps!