Med-Di-Dia

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Regulatory Affairs and Quality Compliance

 

Med-Di-Dia is a regulatory affairs and quality compliance consultancy focusing on the Medical, Digital Health and Diagnostic sectors of the European Life Science Industry.  Our mission is to place regulatory affairs at the heart of every medical technology company and be the 'go to' consultancy for all your regulatory requirements.

 

With passion and drive we have the flexibility to provide a cost-effective, bespoke solution which exactly fits the needs of you, the client.  

 

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TIME CRITICAL SERVICES

Person Responsible for Regulatory Compliance

 

For micro and small companies, we will be your Person Responsible under the new EU Medical Device and In-Vitro Diagnostic Regulations.

 

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Authorised Representative

 

For non-EU and UK companies, we can be your Authorised Representative within Europe.

 

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Legal Representative for EU Clinical Trials

 

For UK organisations running EU-wide clinical trials, we will be happy to act as your Legal Representative to ensure continuity of your trials post-Brexit at a minimal cost.

 

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ONGOING AND ROUTINE SERVICES

 

Help to define your product and develop your regulatory strategy.
Expertise to ensure a successful EU CE Mark registration.
Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)

 

MORE INFORMATION

 

Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).