Quality Management for IVD Devices vs. Medical Devices

How are in vitro diagnostic (IVD) devices similar and different from medical devices? From a quality management system and design control perspective, much is the same in terms of the best practices and tools that can be used to produce a high quality device that is safe and effective for end users. In this episode of the Global Medical Device Podcast, host Jon Speer talks to guest Joanne LeBrun from MDC Associates, who offers valuable insights on the topic of managing quality for in vitro diagnostic devices in relation to that of medical devices as well as the importance of leveraging industry best practices and tools early-on and throughout the product lifecycle.