Linda Chatwin has over 35 years of experience with medical products. Through years of watching regulations evolve and change, she knows how to navigate the global regulatory maze and bring products to market. Ms. Chatwin has obtained approvals for a wide range of products, remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and other regulatory authority audits, and negotiated favorable outcomes with the FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, mock audits, in-depth training on regulatory requirements, and consulting on quality system development and improvement and the MDSAP audit model. She has also conducted numerous trainings and gap assessments for the new MDR as well as SaMD requirements.