Knowledge Center

Dr Kieran Connole, Regulatory Specialist at Med-Di-Dia, will speak about the reality of achieving compliance with the EU MDR at the Galway Technology Centre.  Free tickets via Eventbrite.

In return for just a few hours of your time, you will gain a clear understanding of the key requirements of the new EU Medical Device Regulation (MDR). You will be able to take this knowledge back to your company to help design or update your company-wide approach to achieve full compliance by 26 May 2020.

The deadline for the full enactment of the EU Medical Device Regulation (MDR) is now only just around the corner. By the 26 May 2020, all EU Medical Device companies must be compliant with the requirements of the MDR. At Med-Di-Dia we appreciate the challenges which this sector is facing and to help smooth the journey to full compliance, we want to share our knowledge with you and bust a few myths along the way.

Here’s what we will cover at this first workshop:

• Device Classifications and an overview of the new rules
• Conformity routes for each class including an outline of required documents
• Technical File requirements and other important documentation – overview and when to implement
• The importance of Clinical Evidence for both new and old products

We want to share real life experiences with you so that you can gain from our knowledge obtained through practical, every day work. Registration is via Eventbrite or email: mdd@mddltd.com.  We look forward to seeing you on Tuesday 1st October 2019.