Quality Training

New Medical Device Regulations Business Implementation Workshop

Objectives

The new EU Medical Device and IVD Medical Device Regulations will have far reaching impacts for its many stakeholders and will be transformational for the industry and for Irish medtech businesses.

Not least among the impacts for manufacturers will be the potential need for major investment support to remediate during the 3-5 year business critical transition time frame and significant operating model changes to enable MDR/ IVDR compliance.

Consolidation may be a consequence for smaller and niche manufacturers and the transition period could make EU markets difficult launch markets. Medtech businesses need prepare now for the changes ahead.
Business Implementation Workshop facilitated by EY/ YourEncore

Content includes

- Brief Overview of the Legislation
- Compliance under MDR/ IVDR
- Operational Impact on Functional Teams
- The Implementation Road to Compliance and Business Value 

Who should attend

Preparing for the changes ahead will require involvement at senior levels within organisations and across multiple business functions; stakeholders such as CEO's, CFO's, business leadership, commercial, supply chain managers, QA/RA...

Upcoming dates:

No training dates available at the moment.