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Wednesday, September 30
 

10:15 CEST

Regulating Intelligence: Bringing AI-Powered Medical Devices to the European Market under MDR and the AI Act
Wednesday September 30, 2026 10:15 - 11:00 CEST
Artificial intelligence is transforming medical devices, particularly software-based technologies for early disease detection and personalised healthcare. However, in 2026 AI-powered medical devices in Europe will operate under a dual regulatory framework shaped by Regulation (EU) 2017/745 (MDR) and the Artificial Intelligence Act, creating one of the most complex compliance environments globally.
This session will bring together a Notified Body representative, a startup with an AI-based speech analysis platform for early detection of dementia, Parkinson’s disease and cardiovascular conditions, and regulatory strategy experts. The panel will provide a multidisciplinary and practice-oriented discussion on how innovative AI solutions can successfully reach the European market.
Key discussion points include:
  • Qualification and classification of AI-based software as medical devices
  • Clinical evidence expectations for machine learning systems
  • Lifecycle management of adaptive algorithms
  • Interaction between MDR and the AI Act requirements
  • Data governance and high-risk AI systems
  • Regulatory pitfalls and common deficiencies identified by Notified Bodies
  • Strategic considerations for startups scaling internationally
The discussion will address whether Europe can maintain global competitiveness in digital health while ensuring patient safety and regulatory robustness. By combining regulatory authority perspective, industry experience and strategic advisory insight, this session offers a practical roadmap for innovators navigating AI medical device development in Europe.
Moderators
avatar for Itiziar Alkorta Idiakez

Itiziar Alkorta Idiakez

Professor, Euskal Herriko Unibertsitatea

Speakers
avatar for María Teresa Gómez Manzano

María Teresa Gómez Manzano

Medical Devices Iberia Manager/Medical Devices Lead Auditor, SGS
My professional career began in 2001, at the age of 23, as Quality and Environmental Manager at the multinational company PIMAN, with offices in Alcalá de Henares, Seville, Barcelona, ​​Poland, Morocco, and China, specializing in the metal sector.

Subsequently, in 2002, I joined the consulting firm Alta Calidad Consultores S.L., in the Quality, Environment, and Prevention Department. For the next four years, I held the position of junior consultant and later senior consultant. My responsibilities included providing legal advice... Read More →
avatar for Javier Zaldua Aguirre

Javier Zaldua Aguirre

CEO & CSO, Accexible Impacto

avatar for Talyta Carteano

Talyta Carteano

New Associate Director, Asphalion
Talyta started at Asphalion as Medical Device Manager and Lead Auditor in 2020, bringing over 10 years’ experience in the Medical Devices field. She combines a technical background with a fulfilling career in the fields of regulatory affairs, quality management systems, devices development and leading people.She has proved to be key to the company since the very beginning thanks to her experience, which covers multiple... Read More →
Wednesday September 30, 2026 10:15 - 11:00 CEST
1 Margarita Salas auditorium Azkue Kalea, 1, 48902 San Vicente de Barakaldo, Bizkaia
 
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