The recording of the recent UL AM and UL Health Services webinar, Impact of the New FDA Guidance on 3D Printed Medical Devices, is now available. The US FDA recently released a draft guidance document for medical device manufacturers working with additive manufacturing (AM). According to FDA, the draft guidance is meant to provide manufacturers with the agency’s initial thinking about the technical considerations for manufacturing 3D printed devices, as well as its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.
During this webinar, UL experts speak in detail about the guidance document and what it means from an AM perspective. The UL team will also speak to the medical device industry, what the FDA guidance means from a regulatory approval perspective.
The webinar discusses:
- Medical device design and manufacturing
- Device testing, which includes characterization, validation and verification
- Device regulatory approval
- Additive manufacturing innovation
You will learn:
- How to satisfy requirements of the applicable FDA statutes and regulations for 3D printed medical devices
- Technical considerations to fulfill quality system requirements of the medical device
- The type of information to provide for your FDA submission
Dr. Khalid Rafi, PhD – Additive Manufacturing Lead Development Engineer
Joining UL in 2015, 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.