Quality Training

Quality and Regulatory Forum for Medical Technologies

Objectives

Irish Medtech Association’s Quality & Regulatory Forums represent important face to face networking events for QA/RA specialists in the medtech sector in Ireland. Forum agendas are developed based upon Irish Medtech Association member feedback and in conjunction with the Chair and the Vice-chair of the Forum and members of Irish Medtech Association's Regulatory Steering Committee. Over the last number of years, a major theme of Forum meetings has been the implementation of MDR and IVDR. Forum participants have a unique opportunity to benchmark on wide ranging topical quality and regulatory issues and assess impact to business of same. Typically, industry specialists from across Irish Medtech Association member companies and invited expert national and European speakers (including Notified Bodies/ Competent Authorities etc.) guide Forum participants through topics of interest.

Content includes

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.


QUALITY AND REGULATORY FORUM is an Irish Medtech Association MEMBER ONLY Event

Who should attend

Senior quality and regulatory professionals
Those involved in audits and regulatory compliance

Upcoming dates: