EU postmarket surveillance plans for medical devices-Reference-Cited by-同舟云学术

EU postmarket surveillance plans for medical devices

Published:2019-07-18 Issue:9 Volume:28 Page:1155-1165
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Pane Josep¹²³^ORCID,Francisca Reynold D.C.¹,Verhamme Katia M.C.¹³,Orozco Marcia²,Viroux Hilde⁴,Rebollo Irene³⁵,Sturkenboom Miriam C.J.M.⁶³

Affiliation:

1. Department of Medical InformaticsErasmus Medical Center – University Medical Center Rotterdam Rotterdam Netherlands

2. Department of Patient SafetyAlcon Fort Worth Texas

3. Eu2P European Programme in Pharmacovigilance and PharmacoepidemiologyUniversity of Bordeaux Segalen Bordeaux France

4. Department of Regulatory AffairsHCL Technologies Frisco Texas

5. Department of Patient SafetyNovartis Barcelona Spain

6. Department of Global HealthUniversity Medical Center Utrecht Utrecht Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.4859

Reference27 articles.

1. ISO.ISO 13485: Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes.2016

2. New York Daily News.EU to tighten medical controls after breast implant scandal.2012.http://www.nydailynews.com/life‐style/health/eu‐tighten‐medical‐controls‐pip‐breast‐implant‐scandal‐article‐1.1169444.

3. Safety Communication: Metal‐on‐Metal Hip Implants: Food and Drug Administration;2013.

4. Attorneys Urge FDA Officials To Investigate DePuy Hip Implant Failure Scandal: Walkup Melodia Kelly & Schoenberger;2013.http://www.walkuplawoffice.com/2013/08/29/lawyers‐urge‐fda‐officials‐to‐investigate‐depuy‐hip‐implant‐failure‐scandal/.

5. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.2017.

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