Integrated Risk Management Throughout Device Lifecycle

Notified Bodies and regulatory agencies expect significant risk management activities to be conducted during the development of a medical device, as well as throughout the production and post-production aspects. This includes training, equipment and process issues, purchasing and supplier monitoring, CAPA and complaints and non-conforming products. 

About the presenters

Linda M. Chatwin, Esq, RAC, lead consultant, QA/RA, Emergo by UL

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.

Etienne Nichols, Green Light Guru

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.