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