Med-Di-Dia

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CORE SERVICES

EU AR / PRRC Services

 

We will be your PRRC or EU AR under the new EU Medical Device and In-Vitro Diagnostic Regulations.

 

EU Authorised Representative

EU Market Access

We can help you successfully CE Mark your device under the Medical Device Regulation and In-Vitro Diagnostic Regulation

 

FDA Regulatory Submission

 

We can be your guide for clearance/ approval of your device in the US under  the 510k, PMA or De Novo routes.

 

ONGOING AND ROUTINE SERVICES

 

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).

LATEST INSIGHTS

Understanding the Certificate of Free Sale in the EU: A Comprehensive Guide

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

Selecting the First Market to Enter based on Certificates for Exports: MedTech Compliance in the EU, UK, and USA

Selecting the First Market to Enter based on Certificates for Exports: MedTech Compliance in the EU, UK, and USA

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

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