EATRIS Spotlight - Research workshop

Date and Time

July 15, 2025, 14:00-18:00 WEST

Location

Seminar Room, Champalimaud Foundation, Lisbon

This workshop will provide essential knowledge for researchers aiming to incorporate best regulatory practices into their methodologies, ensuring that innovation in digital health aligns with certification and safety requirements. Its objective is to equip researchers working in the fields of digital health, artificial intelligence, and personalized medicine with a practical framework on regulation, certification, and quality systems applicable to medical devices — including software as a medical device (SaMD).

This in person workshop is a pre-event to MEDICA AI – The Conference.

Key Topics

1. Digitalization in Healthcare and Artificial Intelligence – Practical applications and regulatory challenges.
2. Regulation and Certification of Medical Devices – Standards and requirements for the approval of technological solutions.
3. Quality Systems in Research – Best practices to ensure compliance and safety.
4. Research and Innovation in Portugal.

Programme

14:00 Opening session
14:05 From bench to business: the iMM spin-off portfolio - Carmo-Fonseca (GIMM)
14:20 Is this AI a Medical Device - Miguel Amador (Complear)
14:35 Intro to Regulatory Requirements of MDR/IVDR - Ana Brito (IPN)
15:05 Making It Work: Building Success in Medical Device Development - Patrícia Calado (NTT Data)
15:20 A Lite Quality Management for Research - Miguel Amador (Complear)
16:05 Coffee break
16:30 Understanding Health Institution Exemption: Mastering In-House Production - Patrícia Calado (NTT Data)
17:00 Navigating Clinical Evaluation of Software - Ana Brito (IPN)
17:40 Heka Vision project - Tiago Marques (Champalimaud Foundation)
17:55 Regulatory Pathways for Innovation: INFARMED’s role in supporting Research from Bench to Bedside - Mariana Madureira (INFARMED)
18:15 Closing Session

Participants

Researchers, clinicians, entrepreneurs, and professionals in the biomedical sector who develop or integrate digital health technologies. The workshop will also include representatives from patient associations, such as MamaHelp.

Registration

Free event, but registration is mandatory. Please use the following registration form.

The course is limited to 50 participants.