A validation model for the medical devices industry

• Karen Alexander ^[1] ; P. John Clarkson
  1. [1] University of Cambridge

     University of Cambridge

     Cambridge District, Reino Unido

     
• Localización: Journal of Engineering Design, ISSN 0954-4828, Vol. 13, Nº. 3, 2002, págs. 197-204
• Idioma: inglés
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• Resumen

  • In light of the recent changes to the medical device regulations, manufacturers must now take an integrated approach to design, development and validation. Good design practice encourages this integrated approach while ensuring fitness for purpose within commercial reality. This paper proposes a practical approach aimed at making devices easier and more economic to validate. The approach comes in the form of a model of design for validation that illustrates the basic relationship between design, development and validation, and a series of design tactics that were formulated to help designers take a more proactive approach to validation during design.