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We hosted a webinar on AI & Medical Devices on Tuesday 7 December at 4pm. The use of AI in medical devices continues to develop at pace, driving fundamental changes in the way that healthcare is delivered and regulated in the 21st century. Having just gone through the transition to the Medical Devices Regulation (MDR), stakeholders operating in the EU are now preparing for a planned AI Regulation, a draft of which was published in April of this year. The draft regulation brings significant changes for manufacturers of medical devices that utilise AI and brings additional obligations to their existing MDR requirements.

What are the key issues and challenges that compliance with these requirements will present, and how can they be managed and planned for? This webinar offers perspectives on this topic from legal, technical and notified body points of view.

Speakers:

  • Michaela Herron, Partner, Mason Hayes & Curran LLP
  • James Gallagher, Senior Associate, Mason Hayes & Curran LLP
  • Alexandros Charitou, Associate Partner, UK & Ireland Life Science Commercial Edge and MedTech lead, EY
  • Marco Caproni, Medical Devices Lead Auditor, TÜV Italia, and Senior Product Specialist Software, TÜV SÜD Product Service Gmbh.

To request the webinar recording, please email events@mhc.ie.



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