The FDA case for quality (cfq) provides guidance on how to shift from compliance-centric to product-centric outcome based innovation business models.Cognitive learning outcomes this new strategy relies heavily on digital transformation and harmonization of cross-functional activities that contribute to the safety and efficacy of each device.Cognitive learning outcomes 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.Cognitive learning outcomes 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.Cognitive learning outcomes as moderator, kalypso will showcase industry best practices and leading methodologies. Breakout session sajesh murali, kalypso miguel beltran-delgado, conmed noah cumby, conmed david wolf, kalypso

cognitive learning outcomes

This talk will describe additive manufacturing activities which may not be getting the attention they deserve. Hear from an expert who has helped hundreds of companies incorporate AM into their manufacturing strategies.Cognitive learning outcomes AM is now 30 years old and has advanced to include having certified commercial airplane and medical implants in polymer and metals. In fact, it has progressed to a stage as a legitimate manufacturing technology: most innovative companies are now working through their AM strategy.Cognitive learning outcomes the infrastructure around the technology continues to develop and grow each week. More and more materials producers are trying to understand how they get involved.Cognitive learning outcomes industrial manufacturers are assessing their ability to use the technology to be faster, better or more affordable whilst trying to understand if it is a “make/ buy” for them.Cognitive learning outcomes analytical firms are turning their codes to help automate, simulate and analyze AM. In short, the AM world is now very diverse, very dynamic and very real.Cognitive learning outcomes what does this mean to you? Breakout session john barnes, the barnes group advisors

This presentation will detail a case study of how one of japan's manufacturers eliminated a long-standing global bottleneck on an automotive engine manufacturing line, and the deployment challenges they have faced in their global setting.Cognitive learning outcomes they faced a “broken” manufacturing process which damaged their customer’s lean manufacturing process and its OEM car manufacturing strategy.Cognitive learning outcomes despite the inconsistent data sets across several discrete steps, PTC and the client team adopted a process to undergo the six steps of thingworx analytics in conjunction with a proof-of-concept approach.Cognitive learning outcomes

In this presentation, you will learn how PTC japan’s team focused on unexpected prediction results of failure causes and business outcomes found via the thingworx analytics decision-tree as well as the time-series model provided.Cognitive learning outcomes presenters will share feedback from the manufacturing clients on the successful combination of lean manufacturing and predictive analysis that eliminated waste and increased the throughput, resulting in advanced lean manufacturing.Cognitive learning outcomes additionally, you will learn about recent deployment challenges of this machine learning operationalization at scale for factories in different continents and the need for manufacturing master data in BOM form.Cognitive learning outcomes case study dr. Takeomi imani, PTC