Medical Devices (includes In Vitro Diagnostics)
Recalls involve regulatory obligations, such as Post-Market regulations, complaint handling, Medical Device Reports, and a required report to FDA or appropriate health authority. Also, customer satisfaction plays a significant role in measuring a product’s post market performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes tomonitor and control your post market problems to the FDA under the Corrections and Removals regulation. Those are the easy issues to understand, in reality, it is much more complicated. Learn how by properly conducting correction and removal actions, your firm can help avoid a recall crisis due to key factors that you face in real life experiences, and even use them to your advantage. This session provides up-to-date information from former FDA Recall Expert , Industry Experts and FDA Staff as panel members. Take advantage of steps that will be provided to assistance in demonstrating that firms can have robust quality system to possibly avoid potential recalls and superior customer service during recalls.