Mastering Clinical evaluation for Medical Devices

Mastering Clinical Evaluation for Medical Devices is a webinar designed to provide a comprehensive understanding of the clinical evaluation process in the development of innovative medical devices. Designed for startups in the design and development phase of medical devices, this session offers essential information on regulatory alignment from design and development to clinical studies.

Participants will gain valuable insights from a Clinical Research Organization (CRO) on creating robust clinical evaluation plans, conducting clinical studies, and effectively interpreting clinical data. This will be complemented by a presentation from regulatory experts who will highlight regulatory alignment with clinical trials and CE marking. At the end of the webinar, a company that has recently gone through the process of conducting and presenting a clinical trial and another that is in the initial phase will share their experience.

Program:

14:30 – Opening 

Patrícia Patrício [Health Cluster Portugal]

Marta Passadouro [EIT Health Innostars]

14:35 –Understanding regulatory requirements for clinical evaluation

Sandra Balseiro / Celeste Oliveira [IPN]

15:00 – Clinical Investigation with Medical Devices: Life-cycle phases

Lúcia Domingues / Catarina Silvério [NOVA CRU] 

15:25 – Q&A

15:40 – Real-world Experience of Insparya

João Leite [Insparya] 

15:55 – Real-world Experience of C-mo Medical Solutions

Sara Lobo [C-mo Medical Solutions]

16:10 – Q&A and general discussion with the speakers

16:30 – Closing