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Managing Product Risk from Cradle to Grave; Application of Risk Management in the Development of Medical Devices

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.

This paper was initially prepared for the American Society for Quality (ASQ) May 2014 World Conference on Quality and Improvement, to support a .ppt presentation made at that conference by the author. Responses to questions presented to the author by LNS Research are included in this report, beginning on page 13. This report serves as supplemental material to the corresponding Q3 2014 Global Executive Council webcast. 

Author Name: Ron Makar, DuPont
Date: Oct 8, 2014

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