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

09:00-09:30 Registration

09:30-10:00 High level update on MDR/IVDR current status on the macro environment.

One year to go…

10:00-10:30 Technical documentation under the MDR. A case study

10:30-11:00 Q&A/Discussion

11:00-11:30 Clinical Evaluation under the MDR

11:30-12:00 Q&A/Discussion

12:00-12:30 Lunch

12:30-13:00 Vigilance & Post Market Surveillance under the MDR

13:00-13:30 Q&A/Discussion

13:00-13:30 Economic Operators under the MDR

13:30-14:00 Q&A/Discussion

14:00-15:00 HPRA Update

15:00 Meeting close.


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: