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The 2009 Revision of ISO 14155: A True Worldwide Guidance for Medical Device Companies?

This article was originally published in RAJ Devices

Executive Summary

ISO 14155, the international standard covering medical device clinical investigation, has had its controversies over the past two years. An immature revision was brought out in 2008 and was subsequently voted down by many European Union countries; when it emerged that it had attracted no fewer than 1,100 comments, it was clear that something was wrong.

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The 2009 Revision of ISO 14155: A True Worldwide Guidance for Medical Device Companies?

ISO 14155, the international standard covering medical device clinical investigation, has had its controversies over the past two years. An immature revision was brought out in 2008 and was subsequently voted down by many European Union countries; when it emerged that it had attracted no fewer than 1,100 comments, it was clear that something was wrong.

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