EU postmarket surveillance plans for medical devices

201940 citationsReviewhybrid Open Access

Authors

Josep Pane · Université de Bordeaux

Reynold D. C. Francisca · Erasmus MC

Katia Verhamme · Université de Bordeaux

M. Orozco · Alcon (United States)

Hilde Viroux · HCL Technologies (United States)

Irene Rebollo · Université de Bordeaux

Miriam Sturkenboom ·

Abstract

The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.

Topics & Keywords

Health Systems, Economic Evaluations, Quality of Life Healthcare cost, quality, practices Ethics in Clinical Research

Publication Details

Published in: Pharmacoepidemiology and Drug Safety

Volume 28, Issue 9, pp. 1155-1165

DOI: 10.1002/pds.4859

Field-Weighted Citation Impact: 10.41

Command Palette

EU postmarket surveillance plans for medical devices

Authors

Abstract

Topics & Keywords

Publication Details