Sally Bowden is the Co-Founder and partner of The P3 Acceleration Group and the Founder and CEO of New Precedents. Sally has over 25 years experience in the quality, regulatory and operations field in medical devices and diagnostics. She has served in executive positions as Chief Operating Officer, RenalytixAI, Chief Business Officer and Head of Quality and Regulatory Kantaro Biosciences, Vice President Regulatory, Quality and Operations at Vigilant Biosciences, Vice President of Quality and Process Improvement at Ventana Medical Systems and as Vice President of Quality and Regulatory Compliance at Roche Diagnostics Corporation. She has served as an Associate Professor for Purdue University School of Engineering and Technology, Indianapolis where she developed the Quality Management Curriculum within the Mechanical Engineering Technology department. Sally is a graduate of Purdue University School of Engineering and has also achieved her MBA. Her experience includes working with organizations to not only develop quality systems to meet FDA and global requirements, but also to re-engineer them for efficient, effective compliance. She has developed regulatory strategy for all classes of medical devices. Specifically, she is very successful at Breakthrough Device Designations and single site IVD applications. She helped pioneer the Companion Diagnostic process in collaboration with pharmaceutical and diagnostic firms. In addition, she is very committed to delivering process improvements within the Veteran Administration Health Care System. She is adept at developing and delivering training in all areas of regulatory, quality management and process improvement as well as providing statistical guidance and analysis in all applicable areas of the quality system. Regulatory Affairs, Medical Devices (IVD, AI, EUA, Companion Dx)Quality System Development and Implementation (ISO 13485, 9000, MDSAP)Supplier Management CLIA Lab and LDT DevelopmentCommercial Operation ReadinessGlobal Regulatory and Commercialization SupportLogisics System ImplementationLean and Six Sigma for Advanced Manufacturing and Healthcare Delivery Systems