Med-Di-Dia

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Your Regulatory Partners for Devices, Diagnostics and Digital Health!

EU Market Access | US Regulatory Submissions


Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. We offer a range of services to fit your requirements including:

 

We have the resource, the scientific and technical know-how as well as the regulatory expertise to help fast-track your devices and IVDs to the healthcare services and the patients who are most in need. 

 

Please don't hesitate to contact the team at: 

 

Email: mdd@mddltd.com or Call: +353 (0)91 704804 


  

Free Consultation

CORE SERVICES

EU AR / PRRC Services

 

We will be your EU AR or PRRC 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 and De Novo routes.

 

 

Email: mdd@mddltd.com or Call: +353 (0)91 704804 

 

MORE INFORMATION

 

Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. We offer a range of services under the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) including EU Authorised Representative, for companies placing their products on the European market from small start-ups to multinationals. We also support companies entering the US market in conjunction with our parent company, Global Regulatory Services (GRS). For companies looking to enter Rest of World markets, we can offer regulatory and compliance services to fit your requirements. 

 

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