The quality planning conundrum
Donawa, M.E.
Medical Device Technology 10(6): 14-16
1999
ISSN/ISBN: 1048-6690 PMID: 10623345 Document Number: 502665
Quality planning activity is an important element of a documented quality system. As a result, European and United States quality system requirements include the need to document this activity. However, many medical device companies encounter difficulties in trying to understand exactly how to interpret quality planning requirements. This article discusses these requirements and various approaches to conformity.
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