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).
Risk Management Analysis (ISO 14971:2019)
Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.
15.7.2022
Patient information management (IFU, Labelling and Cartons)
A ‘Label’ is the identity of the product.
15.7.2022
Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)
It allows the identification of specific devices on the market and facilitates their traceability.
15.7.2022