With over 35 years of experience in regulatory affairs and quality assurance, John brings deep expertise in the integration and execution of regulatory and quality management systems across the design, development, and manufacturing lifecycle of medical devices. He has led regulatory strategy and compliance efforts for a wide range of device classes, supporting approvals across U.S., EU, and other global markets. John has advised both established and early-stage medical technology companies, guiding regulatory planning, quality system implementation, and commercialization readiness. John is a Regulatory Affairs & Quality Assurance Consultant with Precision Sciences, Inc. and Insight Navigation, LLC.