Literature DB >> 32011376

Guest Editorial: New Medical Device Regulation in Europe: A Collaborative Effort of Stakeholders to Improve Patient Safety.

Emmanuel Thienpont1, Gianluca Quaglio2, Theodoros Karapiperis3, Per Kjaersgaard-Andersen4.   

Abstract

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Mesh：

Year:  2020        PMID： 32011376      PMCID： PMC7170685          DOI： 10.1097/CORR.0000000000001154

Source DB:  PubMed          Journal:  Clin Orthop Relat Res        ISSN： 0009-921X            Impact factor:   4.755


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  7 in total

1.  Ongoing problems with metal-on-metal hip implants.

Authors:  Carl Heneghan; David Langton; M Thompson
Journal:  BMJ       Date:  2012-02-28

2.  Transparency of clinical evidence for medical devices in Europe - Authors' reply.

Authors:  Alan G Fraser; Eric G Butchart; Piotr Szymański
Journal:  Lancet       Date:  2019-04-27       Impact factor: 79.321

3.  Doctors demand to see evidence on safety of medical devices approved in Europe.

Authors:  Simon Bowers
Journal:  BMJ       Date:  2018-11-30

4.  Europe's new device regulations fail to protect the public.

Authors:  Chris Allan; Thomas J Joyce; Allyson M Pollock
Journal:  BMJ       Date:  2018-10-10

5.  Medical device industry: international investigation exposes lax regulation.

Authors:  Jeanne Lenzer
Journal:  BMJ       Date:  2018-11-25

6.  The need for transparency of clinical evidence for medical devices in Europe.

Authors:  Alan G Fraser; Eric G Butchart; Piotr Szymański; Enrico G Caiani; Scott Crosby; Peter Kearney; Frans Van de Werf
Journal:  Lancet       Date:  2018-07-17       Impact factor: 79.321

7.  Faulty hip implant shows up failings of EU regulation.

Authors:  Deborah Cohen
Journal:  BMJ       Date:  2012-10-23
  7 in total
  3 in total

1.  A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany.

Authors:  Alexander-N Zeller; Elisabeth Goetze; Daniel G E Thiem; Alexander K Bartella; Lukas Seifert; Fabian M Beiglboeck; Juliane Kröplin; Jürgen Hoffmann; Andreas Pabst
Journal:  Oral Maxillofac Surg       Date:  2022-08-22

Review 2.  New regulation of medical devices in the EU: impact in dermatology.

Authors:  J Malvehy; R Ginsberg; L Sampietro-Colom; J Ficapal; M Combalia; P Svedenhag
Journal:  J Eur Acad Dermatol Venereol       Date:  2021-12-06       Impact factor: 9.228

3.  Safety of Medical Devices in Poland - Analysis of Withdrawn and Suspended Certificates of Compliance.

Authors:  Rafał Patryn; Anna Zagaja; Mariola Drozd
Journal:  Med Devices (Auckl)       Date:  2021-07-26
  3 in total

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