Webinar Features
Registration of AI-Enabled Medical Devices Around the Globe
This webinar provides a practical, comparative overview of how AI enabled medical devices are currently regulated across the US FDA pathways, European Union MDR with AI Act considerations, China NMPA, Korea MFDS, Japan PMDA, and ASEAN markets, highlighting classification logic, evidence expectations, and submission pitfalls to support faster and more confident global market entry.
Format
On-Demand Webinar
Level
Beginner
Trainers
Bingshuo Li and Dennis Sarwin
Exam
Certificate of Participation included
Duration
1 hour
Price
Free
Comprehensive Regulatory Expertise
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Flexible Viewing
Gain insights from industry experts and stay updated on the latest trends and regulations without the need to attend live sessions.
Access to Expertise
Meet the Trainer
Bingshuo Li
Bingshuo (Bing) Li, Consultant at Qserve based in Berlin, combines deep expertise in neuroscience and neurotechnology with hands-on experience in regulatory and quality affairs, guiding innovators in translating cutting-edge brain and health technologies into compliant medical devices.
Meet the Trainer
Dennis Sarwin
Dennis Sarwin joined Qserve in May 2022 as a Regulatory Affairs Associate, bringing experience from medical device companies and expertise in global registrations, ISO 13485, and medical device development, backed by a Double Master of Science degree in Integrated Product Design and Biomedical Engineering from TU Delft.
