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The ISO 13485 Introduction course has been designed to provide an insight into the use of ISO 13485:2003 as the basis for a quality management system implemented by medical device manufacturers.
During this ISO 13485 Introduction course, time will be spent reviewing requirements of ISO 13485 and making comparisons to ISO 9001:2008 and the FDA’s Quality System Regulation.
Candidates will also gain an awareness of the relationship between ISO 13485 and ISO 14971:2007 from this Introduction to ISO 13485 course.
Benefits of the ISO 13485 Introduction course:
Course details of the ISO 13485 Introduction course:
Usual duration: One day
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