Description: The introduction and rollout of MDR and IVDR has been a significant stress test for the medtech industry. Organizations that were complacent about the changes or didn’t have the capability to respond quickly found themselves at the back of a long re-certification queue, and facing the prospect of having to remove products from the market. These challenges persist even as deadlines have been extended.
The new EU (and forthcoming UK) regulations have underscored the significant relationship between regulatory and revenue. Organizations with a robust regulatory strategy can turn regulatory changes into competitive advantages. This session discusses some of the key strategic capabilities including regulatory data management, process automation, and tighter alignment with in-country sponsors and Notified Bodies of high-performing regulatory teams, and outlines steps organizations can take to foster stronger regulatory – revenue alignment.
Learning Objectives:
Participants will understand how regulatory activities can have a direct impact on business revenue
Participants will learn how to measure and assess strategic regulatory capabilities in their organizations
Participants will identify areas of alignment where they can strengthen relationships with external (in-country sponsors, distributors, Notified Bodies) and internal (IT, sales, marketing) partners
