Literature DB >> 23097541

How a fake hip showed up failings in European device regulation.

Deborah Cohen1.   

Abstract

Mesh:

Year:  2012        PMID: 23097541     DOI: 10.1136/bmj.e7090

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


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  9 in total

Review 1.  FDA Device Regulation.

Authors:  Madelyn Lauer; Jordan P Barker; Mitchell Solano; Jonathan Dubin
Journal:  Mo Med       Date:  2017 Jul-Aug

2.  Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes.

Authors:  Keith Tucker; Martin Pickford; Claire Newell; Peter Howard; Linda P Hunt; Ashley W Blom
Journal:  Acta Orthop       Date:  2015-09-01       Impact factor: 3.717

3.  Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.

Authors:  Thomas J Hwang; Elisaveta Sokolov; Jessica M Franklin; Aaron S Kesselheim
Journal:  BMJ       Date:  2016-06-28

4.  New risks inadequately managed: the case of smart implants and medical device regulation.

Authors:  Shawn H E Harmon; Gill Haddow; Leah Gilman
Journal:  Law Innov Technol       Date:  2015

5.  Interactive numerals.

Authors:  Harold Thimbleby; Paul Cairns
Journal:  R Soc Open Sci       Date:  2017-04-26       Impact factor: 2.963

Review 6.  Smartphone Sensors for Health Monitoring and Diagnosis.

Authors:  Sumit Majumder; M Jamal Deen
Journal:  Sensors (Basel)       Date:  2019-05-09       Impact factor: 3.576

7.  Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee.

Authors:  Stefan Sauerland; Naomi Fujita-Rohwerder; Yvonne Zens; Sandra Molnar
Journal:  BMJ Open       Date:  2019-02-22       Impact factor: 2.692

8.  Introduction and adoption of innovative invasive procedures and devices in the NHS: an in-depth analysis of written policies and qualitative interviews (the INTRODUCE study protocol).

Authors:  Sian Cousins; Hollie Richards; Jesmond Zahra; Daisy Elliott; Kerry Avery; Harry F Robertson; Sangeetha Paramasivan; Nicholas Wilson; Johnny Mathews; Zoe Tolkien; Barry G Main; Natalie S Blencowe; Robert Hinchliffe; Jane M Blazeby
Journal:  BMJ Open       Date:  2019-08-26       Impact factor: 2.692

9.  Drugs and Devices: Comparison of European and U.S. Approval Processes.

Authors:  Gail A Van Norman
Journal:  JACC Basic Transl Sci       Date:  2016-08-29
  9 in total

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