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LiveWorx 2019

LS894B - Accelerating Medtech Innovation with Proactive Regulatory Strategies, RIM, and Closed-Loop Quality

Session Description

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.


Session Presenter
Additional Information
Life Sciences
Compliance & Regulatory Oversight
The FDA’s Case for Quality goals and initiatives has huge implications for medical device manufacturers but is attainable with a process-driven approach to digital transformation
Implementing a closed-loop quality management system within their product development environments enables companies to reduce cycle times and improve quality
Collaborative strategies and approaches should be considered when implementing PLM & QMS in the same system
Breakout Session
45 minutes
Session Schedule