Literature DB >> 22637765

Rethinking medical device regulation.

Carl Heneghan, Mathew Thompson.   

Abstract

Mesh：

Year:  2012        PMID： 22637765      PMCID： PMC3360534          DOI： 10.1258/jrsm.2012.12k030

Source DB:  PubMed          Journal:  J R Soc Med        ISSN： 0141-0768            Impact factor:   5.344


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  9 in total

Review 1.  Medical device development: from prototype to regulatory approval.

Authors:  Aaron V Kaplan; Donald S Baim; John J Smith; David A Feigal; Michael Simons; David Jefferys; Thomas J Fogarty; Richard E Kuntz; Martin B Leon
Journal:  Circulation       Date:  2004-06-29       Impact factor: 29.690

2.  The saga of Poly Implant Prosthese breast implants.

Authors:  Carl Heneghan
Journal:  BMJ       Date:  2012-01-11

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

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

Review 4.  Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.

Authors:  Sanket S Dhruva; Lisa A Bero; Rita F Redberg
Journal:  JAMA       Date:  2009-12-23       Impact factor: 56.272

5.  Medical device recalls and the FDA approval process.

Authors:  Diana M Zuckerman; Paul Brown; Steven E Nissen
Journal:  Arch Intern Med       Date:  2011-02-14

6.  How are medical devices regulated in the European Union?

Authors:  Elaine French-Mowat; Joanne Burnett
Journal:  J R Soc Med       Date:  2012-04       Impact factor: 5.344

7.  Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts.

Authors:  C Heneghan; M Thompson; M Billingsley; D Cohen
Journal:  BMJ Open       Date:  2011-05-15       Impact factor: 2.692

8.  The NICE Medical Technologies Evaluation Programme (MTEP): manufacturer submission challenges.

Authors:  Kirsty Sprange; Maxine Clift
Journal:  J R Soc Med       Date:  2012-04       Impact factor: 5.344

9.  Regulation of medical devices outside the European Union.

Authors:  Susan Lamph
Journal:  J R Soc Med       Date:  2012-04       Impact factor: 5.344
  9 in total

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