14h30
Understanding Medical Devices Regulation
Opening
Health Cluster Portugal
Marta Passadouro
EIT Health Innostars
Os webinars JoinHealth Spring series de 2024 prometem uma visão abrangente das transformações, desafios e oportunidades na saúde digital, no âmbito do projeto DigiHealthPT
Sobre
JoinHealth – Spring welcome series
O próximo ciclo de webinars JoinHealth spring series decorre entre os meses de abril e maio, trazendo para a agenda um conjunto de temas no âmbito do projeto DigiHealthPT.
Os webinars JoinHealth Spring series de 2024 prometem uma visão abrangente das transformações, desafios e oportunidades na saúde digital, no âmbito do projeto DigiHealthPT. Contamos com a vossa participação nestas sessões, que serão conduzidos em inglês, e proporcionarão uma valiosa oportunidade de aprendizagem e networking para os profissionais do setor.
Bilhetes e Registo
09 de Abril
Understanding Medical Devices Regulation
16 de Abril
How to get your Digital Therapeutics (DTx) reimbursed in Europe
07 de Maio
Software as a Medical Device and the regulatory implications of AI
14 de Maio
Mastering Clinical evaluation for Medical Devices
Programa
14h30
Understanding Medical Devices Regulation
Opening
14h35
Essential steps for CE mark
14h55
Q&A
15h05
Technical and usability requirements according to the MDR: Case study
15h25
Q&A
15h35
CE Marking Success Story: Difficulties in the transition from Directive 92/43/CE to European Regulation 2017/745
15h50
CE Marking Success Story: Mastering European Regulation 2017/745 for the first time
16h05
Q&A and general discussion with the speakers
16h15
Closing
14h30
How to get your Digital Therapeutics (DTx) reimbursed in Europe
Opening
14h35
Early Access to Reimbursement for Digital Medical Devices (PECAN) in France
14h55
Q&A
15h10
The Belgian mHealth reimbursement framework: an exercise in digital care pathways
15h30
Q&A
15h45
Hope Care's Experience with the Reimbursement Systems in France and Germany
16h00
16h10
Closing
14h30
AI Act and the impact in Medical Devices Regulation
Opening
14h35
Software as a Medical Device: Good Practices
Topics:
14h50
AI Software: Good Practices
Topics:
15h05
Q&A
15h15
European Regulation for Software as a Medical Device
Topics:
15h30
European Regulation and AI ACT
Topics:
15h45
Q&A
15h55
Real world Example: Peeking Window
16h05
Real world Example: Digestaid
16h15
Q&A and general discussion with the speakers
16h30
Closing