The US FDA has released draft guidance for medical device manufacturers working with additive manufacturing (AM). According to FDA, the draft guidance is meant to provide manufacturers with the agency’s initial thinking about the technical considerations for manufacturing 3D printed devices, as well as its thoughts on characterizing and validating such devices. In this recording of a one-hour live webinar, UL experts speak, in detail about the new FDA guidance document and what it means from an additive manufacturing perspective. Our team of expert co-presenters also speak to the medical device industry, what the FDA guidance means from a regulatory approval perspective and also took time to answer questions from a live audience of almost 300.
This webinar was delivered Wednesday, October 12, 2016.
Simin Zhou – Vice President, Digital Manufacturing Technologies
Simin leads Digital Manufacturing Technologies at UL. Her work in 3D Printing & Additive Manufacturing focuses on providing widely available training and education, simplifying and improving compliance of equipment and materials, and developing infrastructure to support quality and safety of 3D printed parts and products. Simin serves on the Governance Board of America Makes and the Advisory Board of Milwaukee School of Engineering Rapid Prototyping (Additive Manufacturing) Center. Simin holds an MBA from Harvard Business School and graduated summa cum laude in Computer Engineering from University of Minnesota. Simin also has hands-on software engineering and product management experience from ADC Telecom, Tyco Healthcare, 3M and Intel. She is passionate about technology and innovation.
Dr. Khalid Rafi, PhD – Additive Manufacturing Lead Development Engineer
Joining UL in 2015 as a Lead Additive Manufacturing (AM) Development Engineer, Khalid Rafi is responsible for the development of AM materials validation and process validation programs at UL’s Global AM Center of Excellence in Singapore. Leveraging his 14 years of experience in teaching and research, Rafi is also engaged in the development and delivery of UL’s AM training program.
Rafi is recognized as one of the few established metallurgists within the AM industry. His research focuses on process optimization, materials characterization and developing structure-property correlations for metallic parts produced using additive manufacturing techniques including selective laser melting (SLM), electron beam melting (EBM) and ultrasonic consolidation (UC).
Rafi holds a Masters and PhD in Materials and Metallurgical Engineering from the Indian Institute of Technology, Madras, India and has earned a post-doctoral fellowship from the University of Louisville, Kentucky, USA and Nanyang Technological University, Singapore.
Linda Chatwin, J.D., RAC – Senior Regulatory Consultant
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the regulatory maze required to bring products to market. She holds a Regulatory Affairs Certification and is holds a Juris Doctor degree. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Currently, she heads the North American Advisory Services group for UL, LLC, assisting clients with regulatory issues and challenges, including implementation of UDI processes. Ms. Chatwin travels worldwide to speak about changing market access issues.