In the evolving landscape of diagnostics, the FDA LDT rule emphasizes the necessity for robust quality management systems (QMS). Join Promega and McDermott for an informative webinar that explores the significance of these systems in developing IVD assays. McDermott will provide an overview of the FDA rule, its phases, and the critical role of a QMS in compliance. Promega will showcase how laboratory quality systems can leverage their existing ISO-certified quality framework to streamline FDA submissions. This webinar will equip you with considerations for building an effective QMS, ensuring regulatory compliance and enhancing the reliability for your IVD assays.
What you will learn:
- The role of a quality management system in compliance with the FDA LDT rule
- How the FDA will approach LDT assay modifications
- Key to leverage a manufacturer’s quality management systems