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

Risk Management Analysis (ISO 14971:2019)

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)

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)

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