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

EU AR and EU Market

EU AR and EU Market

Operating without an EU Entity?
You could be at risk of a Product recall, Penalty or legal action!

6.3.2023

ISO 13485 Importance

ISO 13485 Importance

When it comes to medical device manufacturing, patient safety depends on the quality and consistency of medical products.

2.3.2023