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Keywords: Medical device manufacturer
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Journal Articles
Developing a quality management system implementation process for a medical device manufacturer
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Journal of Manufacturing Technology Management (2015) 26 (7): 955–979.
Published: 07 September 2015
...Eduardo Gadotti Martins; Edson Pinheiro de Lima; Sergio E. Gouvea da Costa Purpose – The purpose of this paper is to develop and test a quality management system (QMS) implementation process for a medical devices manufacturer, which are covered by ISO 13485:2007 and RDC No. 59:2000 and based...
