World Conference on Quality and Improvement vol. 68 - May 2014
Abstract: A risk management strategy was developed for a DuPont business dedicated to the development of medical devices. This strategy took into consideration five different forms of risk: risk associated with product development, risk associated with the manufacturing process, risk associated with business scenarios, risk associated with stewardship of the product and risk associated with post-market surveillance.
Keywords: Risk management; Product development; ISO 14971:2007; ISO 13485:2003; Medical devices; Product risk management; Process risk management; Business risk management;
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