Quality and Regulatory Forum
Updates from the following Irish Medtech MDR Implementation Task Forces will be delivered on the day with a particular focus on Clinical Evaluation and Evidence;
- Clinical Evaluation Task Force
- Classification & Scope Task Force
- IVD Specific Task Force
- QMS Impacts Task Scope
On the day, there will be an hour long session on Eudamed delivered by the consultant that designed and developed the system.
For the past 8 years Richard Houlihan has been working with the European Commission on Eudamed, Eudamed 2 since 2011 and then MDR Eudamed since 2017. Richard was the technical manager responsible for the design, development, and implementation of the MDR Eudamed application and the associated data exchange for machine-to-machine XML uploads.