Webinar: AI & Medical Devices
Event Date: 07 December 2021
We will host 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 will offer perspectives on this topic from legal, technical and notified body points of view.
- 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.
Alexandros has over 25 years of experience in healthcare and life sciences supporting medical technology, diagnostic and pharmaceutical companies across the product development journey, including clinical evidence generation, regulatory strategy, quality management systems and safety processes.
As a former Notified body in-house clinician, Alex is a subject matter expert on European medical device regulatory and commercial strategy as well as the new European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR). He has worked extensively with regulatory, medical affairs and safety teams globally as well as European regulators. He has a special interest in software as a medical device, wearables and device drug-device combination products.
Alex studied medicine at the Royal Free Hospital in London and followed on with higher surgical training in cardiothoracic and major trauma surgery. He was a cardiothoracic surgeon in the UK and clinical lead for chest trauma, responsible for developing and running the chest trauma service at one of London's major trauma centres.
Marco Caproni holds a MSc in biomedical engineering. He joined TÜV Italia (TÜV SÜD Italian subsidiary) in 2018 as Product Specialist for active medical devices. His role in TÜV SÜD Product Service Gmbh Notified Body is Senior Product Specialist of Software (MDA 0315).
He has 12 years of professional experience in the design and development of medical devices, in the area of software, extracorporeal circulation devices (such as dialysis) and has worked as software- and active medical devices-focused certification lead auditor.
As Lead Auditor, Project Handler and Technical Documentation assessor, Marco is actively driving conformity assessment activities for active medical devices customers in Italy and internationally. As Senior Product Specialist, Marco is the ultimate responsible for answering technical questions, making decision in case of unclear requirements about MDA0315 and software in general.
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