In the evolving regulatory landscape for diagnostics, the FDA LDT rule emphasizes the necessity for robust quality management systems (QMS) and their significance in IVD assay development. McDermott Will & Emery LLP will provide an overview of the FDA rule, its phases, and the critical role of a QMS in compliance. Promega will demonstrate how laboratory quality systems can leverage its ISO-certified quality framework to streamline FDA submissions. This workshop will equip you with considerations for building an effective QMS, facilitating regulatory compliance and enhancing the reliability of your IVD assays. Time will be allotted for a Q&A session.
