LS894B - Accelerating Medtech Innovation with Proactive Regulatory Strategies, RIM, and Closed-Loop Quality
The FDA Case for Quality (CfQ) provides guidance on how to shift from compliance-centric to product-centric outcome based innovation business models. This new strategy relies heavily on digital transformation and harmonization of cross-functional activities that contribute to the safety and efficacy of each device. Once implemented, regulatory imperatives like EU MDR, UDI, and EUDAMED become more easily managed and a competitive differentiator as regulatory information management (RIM), product BOM’s, documents, changes, non-conformances, complaints and CAPA’s are part of one integral system. In this session, leading medical device manufacturers will present how they are implementing proactive regulatory and quality business strategies within their businesses, milestones to date, and lessons learned along the way. As moderator, Kalypso will showcase industry best practices and leading methodologies.