Clinical evaluation

opinions provided under the Clinical Evaluation Consultation Procedure

Expert panel opinions on clinical evaluations: procedure and synthesis of consultations

By Guillaume Promé
Oct. 24, 2022 • Clinical evaluation

Opinions of expert groups in the clinical evaluation of medical devices

PMCF : Post Market Clinical Follow-up

PMCF: Post-Market Clinical Follow-up for Medical Devices, Guidance

By Guillaume Promé
Dec. 21, 2021 • Clinical evaluation, Regulation (EU) 2017/745

Summary of PMCF requirements: Post-Market Clinical Follow-up of medical devices, according to Regulation 2017/745 (definition, methods, expected documents…)

Clinical evaluation medical devices

Clinical evaluation of Medical Devices

By Guillaume Promé
Sep. 30, 2021 • Clinical evaluation

Introduction to the clinical evaluation of medical devices and corresponding regulatory requirement to obtain and maintain the CE marking