| Date & Time | 24 June 2025 at 10:00-18:00 CEST |
|---|---|
| Address | Institudo Pedro Nunes, R. Pedro Nunes, Alto de São João, 3030-199 |
| Location | Coimbra, Portugal and Online |
We are pleased to announce the Medical Device Roadmap event, organised by Instituto Pedro Nunes (IPN), Association for Innovation and Biomedical Research on Light and Image (AIBILI), and Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), as part of the EATRIS Spotlight Programme initiative. The event will take place on 24 June 2025 at Instituto Pedro Nunes in Coimbra and will focus on the development, regulation, and clinical application of AI-enabled medical devices.
This event aims to bring together experts from academia, industry, regulatory authorities, and patient organisations to address critical challenges in clinical validation, CE marking, and compliance with the EU Medical Device Regulation.
The Medical Device Roadmap event presents a unique opportunity to foster cross-sector collaboration and contribute to the advancement of healthcare innovation.
Registration is open here.
Keep up to date with any updates here.
Agenda (all times in CEST)
10:00 – Event Opening
10:30 – EATRIS Digital HUB
Florence Bietrix (EATRIS) [remote]
10:55 – From Concept to Implementation of AI Models: A Researcher’s Perspective
Luis Mendes (AIBILI) [remote]
11:20 – Clinical Investigation of Medical Devices
Mario Ribeiro (AIBILI)
11:45 – Coffee Break and Networking
12:15 – Navigating the CE Marking Process for AI-Enabled Medical Devices
Ana Brito (IPN)
12:45 – Industry Perspective: Challenges in Implementing the European Medical Device Regulation
Mariana Tiberio (APORMED)
13:10 – Regulatory Scrutiny: The Notified Body’s Role in AI Medical Device Certification
Agnese Mengoli (TUV SUD)
13:35 – AI in Medical Devices: Compliance from a Competent Authority’s Lens
Mariana Madureira (Infarmed)
14:00 – Lunch and Networking
15:00 – Neurotechnology and BCIs: From Innovation to Clinical Validation – The g.tec Journey
Christopher Guger (gTec Austria)
15:45 – Clinical Applications of Brain-Computer Interfaces: The BCIAUT and PowerAut/CaixaImpulse Trials
Miguel Castelo-Branco (CIBIT/ICNAS)
16:15 – Clinical Trials Using Brain Stimulation Devices: The STIPED Project
Catarina Pereira (CIBIT/ICNAS)
16:40 – Coffee Break and Networking
17:10 – Integrating Patient Associations in Medical Device Research and Validation
Elsa Vieira / Marta Teixeira (APPDA)
17:30 – Closing Session
