Managing Product Risk from Cradle to Grave

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;

Access this article
Other ways to access this article
You will need Adobe Reader to view this PDF document. Download the free Reader from Adobe

Featured advertisers


(0) Member Reviews

Featured advertisers

ASQ is a global community of people passionate about quality, who use the tools, their ideas and expertise to make our world work better. ASQ: The Global Voice of Quality.