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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

Different types of ISO 13485 Audits

Different types of ISO 13485 Audits

Audits are a key component of ISO 13485:2016

30.11.2022

EURLs IVDR

EURLs IVDR

What are EU Reference Laboratories under IVDR? EURLs

9.11.2022

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

ISO 13485:2016 – your partial gateway towards market entry around the World!

24.10.2022