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).
Understanding the Certificate of Free Sale in the EU: A Comprehensive Guide
A Certificate of Free Sale (CFS) is an essential document for manufacturers & authorised representatives looking to export medical devices outside EU
23.10.2024
Here’s a breakdown of the certificates from each region and factors to consider for the first market entry.
2.10.2024
Understanding Device Classification and Predicate Device Searches in the US
Launching a medical device in the United States requires navigating a complex regulatory environment governed by the U.S. Food and Drug Administration
13.8.2024