Sponsored by:

Complimentary Webinar Recording

| RECORDED ON September 28, 2023 |

MDR & IVDR Lessons for Regulatory Strategy


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.


  • Regulatory Affairs Professional in the MedTech Industry


  • You will understand how regulatory activities can have a direct impact on business revenue
  • How to measure and assess strategic regulatory capabilities in their organizations 
  • Identify areas of alignment where they can strengthen relationships with external (in-country sponsors, distributors, Notified Bodies) and internal (IT, sales, marketing) partners


James Gianoustos

James Gianoutsos
Founder & CEO
Rimsys Regulatory Management Software

James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software. James is a quality assurance and regulatory affairs professional whose professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. James has extensive experience in establishing and maintaining quality management systems and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) from the University of Pittsburgh – Katz Graduate School of Business.

Share This