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

AI-Airlock: MHRA’s new way to test and regulate AI in healthcare

AI-Airlock: MHRA’s new way to test and regulate AI in healthcare

AI is transforming the healthcare sector in many ways, from improving diagnosis and treatment to providing personalised care and support.

1.2.2024

CE Mark extension is NOT Automatic

CE Mark extension is NOT Automatic

The EU MDR extension for certain medical devices only allows you up until 31st December 2027 or 2028 if you have a signed contract..

29.1.2024

Understanding Serious Injuries Caused by Medical Devices: What Happens Next?

Understanding Serious Injuries Caused by Medical Devices: What Happens Next?

Prioritise patient safety with these steps!

27.10.2023