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US quality system regulations have worldwide impact

This article was originally published in Clinica

Executive Summary

Medical device manufacturers face many new regulatory requirements and a bill of $81.9 million as a result of the US FDA's new Quality System Regulation which replaces previous good manufacturing practice requirements. Despite the cost and complexity, the regulations look likely to be beneficial to the industry, not least because the greater harmonisation of the regulations than in the past should help US manufacturers sell their products worldwide. In the first of two articles, Jonathan Kahan reviews some of the highlights of the new regulations.

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