Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective

AboutOpen

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Field Value
 
Title Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
 
Creator Fennema, Peter
Achakri, Hassan
 
Description  On 26 May 2017, the Medical Devices Regulation (MDR 2017/745) was published, with the aim of replacing the current Medical Devices Directive (MDD 93/43/EC). Following a transition period of 3 years, this regulation will be applied in full from 26 May 2020. This article describes and discusses the impact of MDR on the clinical evaluation and gives advice to manufacturers on the preparation, planning and implementation of processes to support compliance with the new regulation. (Market Access)
 
Publisher Aboutscience Srl
 
Date 2019-07-31
 
Type info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
 
Format application/pdf
text/html
application/epub+zip
 
Identifier https://journals.aboutscience.eu/index.php/aboutopen/article/view/294
10.33393/abtpn.2019.294
 
Source AboutOpen; V. 6 N. 1 (2019): January - December 2019; 70-75
AboutOpen; Vol 6 No 1 (2019): January - December 2019; 70-75
2465-2628
 
Language eng
 
Relation https://journals.aboutscience.eu/index.php/aboutopen/article/view/294/262
https://journals.aboutscience.eu/index.php/aboutopen/article/view/294/263
https://journals.aboutscience.eu/index.php/aboutopen/article/view/294/264
 
Rights Copyright (c) 2019 The authors
http://creativecommons.org/licenses/by-nc-nd/4.0
 

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