Why Supplier Quality Management Is So Important For Medical Device Companies

This is a podcast episode titled, Why Supplier Quality Management Is So Important For Medical Device Companies. The summary for this episode is: Effectively managing suppliers, vendors, consultants, and other third party entities that provide products and services can be challenging. How, what, and when do medical device companies manage relationships between those in the company and those outside of the company? Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to review and discuss the details of supplier quality management. Some of the highlights of the show include: - What is supplier quality management? Anybody outside the main company that provides products/services that directly/indirectly go into medical devices. - Why supplier quality management is important? Manufacturers must use good judgement when establishing and meeting quality system (QS) requirements. - Necessary evil or supplier quality management failure? Used for years, Ethylene Oxide (EtO) sterilization for medical devices is now a public health emergency. - EtO is flammable, carcinogenic, and key ingredient in thermobaric weapons. Companies should identify and consider other options for valid sterilization. - Defining critical vs. non-critical is not enough. Use risk-based approach when assessing criticality levels of suppliers for your products and processes.