How to secure AI Powered Medical Devices?

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  Michal Kucharski Director, Product Security Officer - Strategy & Governance @ Fresenius Medical Care

  Director, Global Product Security Officer at Fresenius Medical Care, leading strategy, governance, and execution of product security across global R&D. With over 20 years of experience in cybersecurity, regulation, and risk management, he has built a career delivering security programs that balance patient safety, compliance, and operational reality. At Fresenius, Mike established and directs the Product Security Office (PSO), embedding security practices across software, hardware, and connected systems. He also chairs the Product Security Governance Committee (PSGC), ensuring cross-functional alignment with international regulations while maintaining engineering agility and business continuity. His work spans the world’s most demanding frameworks, including FDA Section 524B, EU MDR/MDCG cybersecurity provisions, China’s NMPA guidance, and standards such as IEC 81001-5-1, IEC 62443-4-2, ISO 14971, and ISO 13485.

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  Alexis Ruiz AI Medical Expert @ DEKRA

  Master's degree in Biomedical Engineering from the Technische Hochschule Lübeck, with more than 8 years of experience in the medical device industry. Specialized in medical software development and regulatory compliance under the MDR/IVDR, AI Act and other regulations. Member of technical committee IEC TC 62/PT 63450 “AI enabled medical devices – methods for the technical verification and validation”  National expert for CEN/CENELEC JTC21 on AI, participating in WG2 & WG3  Member of IEC Task Force AI and Digital Transformation  Member of ISO/CASCO JWG6 “Conformity Assessment Schemes for AI systems” 

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  Gea Bianchi Software Quality Senior Engineer & Cybersecurity Authority @ FLEX

  She is a biomedical engineer passionate about integrating medical technologies safely and securely. Since joining Flex in 2019 as a Software Quality Engineer, in 2024 she was entitled with the role of Cybersecurity Authority. In this role, she coordinates cybersecurity activities within Flex's Healthcare Solutions division, align our Quality Management System with current standards, perform threat modeling and risk assessments, and promote product security awareness. She recently began collaborating on the development of IEC 81001-5-2.

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  Alessandro Vitiello Managing Director @ D.med Software

  Alessandro Vitiello is a recognized professional in software development and engineering. He holds an Engineering degree from Parthenope University in Naples and began his career in 2015 at D.med Consulting as Head of Software Development. There, he built a strong software and cybersecurity team that delivered solutions aligned with rigorous MedTech standards. He later became Managing Director of D.med Software, strengthening his leadership in the industry. Known for his strategic vision and innovation in healthcare technology, Alessandro consistently drives growth and excellence.