Episode description

This presentation and panel was recorded 4 October 2024. We encourage you to download the slides presented during this session by ⁠⁠⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions!

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Thank you for tuning in. 🙏

Join us for an exclusive panel discussion featuring top experts from TÜV SÜD, GMED, and BSI as they dive into the intricacies of structured dialogue between MedTech manufacturers and notified bodies. As regulatory expectations continue to evolve under MDR and IVDR, these dialogues are vital for ensuring compliance and expediting market access.

Our panelists will provide valuable insights into key topics such as: 

• Effective strategies for engaging with notified bodies in structured dialogues
• Managing device classifications, submission processes, and project timelines
• How to navigate changes in notified bodies and maintain compliance
• Best practices for developing regulatory plans in new technology areas 

This session is ideal for regulatory professionals, quality assurance teams, and MedTech manufacturers seeking practical guidance on optimizing their interactions with notified bodies. 

Don't miss this opportunity to learn from leading voices in the industry and gain actionable strategies to ensure regulatory success. This session will be invaluable for anyone navigating MDR/IVDR compliance.

Panelists: 

• Alex Laan – Head of the IVD Notified Body, BSI
• Dr. Andreas Stange – Senior Vice President MHS Regulatory & Quality, TÜV SÜD
• Tom Patten – IVDR/IVD International Manager, GMED 

Moderator: 

• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ 

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