Navigating the new MDR - Strategies for Success

April 10, 2018

In cooperation with MedicSense Ltd. and the Embassy of Denmark, Israel, MEDEI Aps, is hosting a morning seminar titled Navigating the new MDR - Strategies for success. The goal of the seminar is to shed light on the regulatory changes and to share knowledge and experience within the area to better prepare for the upcoming challenges. With recent updates in regulations and the new MDR, more focus is being placed on clinical evaluation. This places a higher strain on both regulatory and clinical operations. All manufacturers will have to keep a closer eye on their clinical evidence if they want to reach (or keep their foothold in) the EU market. The seminar is being held at the Hotel Metropolitan in Tel-Aviv Israel.

Navigating the new MDR: Topics addressed

  • The regulatory landscape for medical devices – what‘s the new MDR all about and how does it affect manufacturers?
  • The importance of digitization and clinical data for medical device manufacturers. Why is this becoming more important?
  • The do‘s and don‘ts of conducting clinical studies for medical devices - learning from experience
  • Cooperation with vendors and clinical teams - opportunities and challenges

The speakers for the seminar include:

Charlotte Slente, the Ambassador of Denmark, Israel to open the seminar Adi Ickowicz, Founder & CEO of MedicSense Ltd. who will address the topic of the regulatory landscape of the new EU MDRJan O. Ovesen, MD. , Co-Founder, Chairman of MEDEI ApS will share about The importance of clinical data for medical innovations Cooperating with clinical organizations on clinical studies for medical devices - how, why, when?Ygal Rotenstreich, MD. , Head, Electrophysiology Clinic, Goldschleger Eye Institute, Sheba Medical Center, Israel. Director, Retinal Research Laboratory Goldschleger Eye Institute, Sackler faculty of Medicine Tel Aviv UniversityDan J. Gelvan, PH.D., Executive Vice President of PolyPid will address the topic of Medical device clinical operations, the do's and don'ts - a personal review.Jon I. Bergsteinsson, Co-Founder and VP of Global Business Development, MEDEI ApS will close the seminarIf this topic sparked your interest read our blog post on The 3 C's of the new EU MDR: Changes, Challenges and Contributions. The focus is on trust, transparency, and traceability to create a safer 'healthcare ecosystem'. Registration has closed as the seminar is taking place on the 10th of April. You can contact for further information.