On 24 February 2025 ECM will participate as a featured speaker at the webinar “Clinical Evaluation under MDR explained by a Notified Body” organized by the RAPS Quebec Local Networking Group.

As a leading Notified Body No. 1282 under the Medical Device Regulation (MDR), ECM is dedicated to provide companies and professionals with clear and accurate information on the major and most recent regulatory issues. In line with this commitment, we are pleased to announce our participation in the upcoming virtual event, organized by the RAPS Quebec Local Networking Group.

This interactive webinar, scheduled for Monday, 24 February 2025, represents an important opportunity to explore one of the most critical aspects of MDR compliance: the clinical evaluation requirements under MDR.

WHAT TO EXPECT FROM THE WEBINAR

During the session, ECM’s Clinical Manager, Dr. Riccardo Persia, will provide a comprehensive overview of the following topics:

• MDR Article 61(10) on demonstration of conformity to General Safety and Performance Requirements (GSPRs) when clinical data is unavailable;
• MDCG 2024-10 Provisions on the clinical evaluation of orphan medical devices.

WHY ATTEND?

This webinar offers medical device manufacturers and professionals an opportunity to deepen their understanding of the clinical evaluation requirements under the MDR. By joining this event, participants will:

• Enhance their understanding of MDR provisions related to clinical evaluation;
• Learn directly from an expert in the field of regulatory compliance;
• Engage directly with a clinical expert from a Notified Body.

ECM’S COMMITMENT TO MANUFACTURERS

At ECM, our role as Notified Body is to independently assess and verify the conformity of medical devices to the rigorous standards set by MDR. Through initiatives like this webinar, we aim to promote a better understanding of regulatory requirements, empowering stakeholders to remain updated and aligned with the latest industry standards.

EVENT DETAILS

Date: Monday, February 24, 2025 Time: 11:00 AM to 12:00 PM (Eastern Time, US & Canada) Location: Online

The event is free for RAPS members and available to non-members for a small registration fee.