is being presented by Bill White, Senior Consultant, with Quality System Strategies LLC and airs on Thursday, March 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Management of product risk is not addressed prominently either in the FDA’s Quality System Registration or in ISO 13485:2003. Nevertheless, in order to ensure the well being of customers and the company itself, each medical device company must incorporate product risk management concepts throughout its quality management system. The Global Harmonization Task Force issued a guidance document which provides an excellent starting point in identifying the processes that need to include risk management. However, going beyond the guidance document calls attention to both opportunities and pitfalls in product risk management.
This audio conference reviews senior management responsibilities and benefits related to product risk management. The speaker identifies the risk management principles to be incorporated throughout the quality management system, with particular emphasis on links between processes.
