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).