Who we are

We are passionate about all things regulatory especially in the complex environment of Medical and Digital technology.  We will cut through the maze of regulations and be a risk partner on the journey to the market never forgetting that, at journey's end, patients will be the beneficiaries.  

 

Med-Di-Dia was spun out of Global Regulatory Services to provide the key services of:

 

EU Authorised Representative
EU Person Responsible for Regulatory Compliance
EU Legal Representative for Clinical Trials

EU MDR and IVDR Regulatory Compliance 

US FDA Regulatory Compliance

 

With a dedicated team, we will be your launchpad into Europe and the US.

 

We get a buzz from seeing a product on the market which we've helped to get there.  The thrill of knowing that we've guided that company through the maze of regulations, liaised and negotiated with the authorities and finally, there it is and available to everyone.  Above all, we know that we've helped to ensure the product is safe, of good quality and that it works.  This is one of the best feelings in the world.

 

Why Galway?  It is a hotbed of innovation especially for the MedTech sector.  The Med-Di-Dia team is embracing every aspect of Galway life.  We will be supporting start-ups, entrepreneurs and well established MedTech companies.  We will promote regulatory affairs as a 'cool' career and help to develop the next generation of regulatory professionals.

 

If you want to go global, no problem!  Med-Di-Dia has the full support of Global Regulatory Services' worldwide network of consultants who provide in-country knowledge as well as regulatory expertise.