is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, February 16th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Supply chains for medical devices are growing in importance as device manufacturers outsource products and services. As some of this outsourcing moves offshore and to low-cost countries, the supply chain becomes longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function.
FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. However, in February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers, and this guidance document has become the global de facto standard for supplier management.
This audio conference presentation helps attendees understand the regulations and the expectations of the GHTF guidance document, and how to go about implementing its provisions.
