Date & Time
Starts
Mar 20, 2025 10:00am KST
Ends
Mar 23, 2025 5:00pm KST
Location
COEX Convention & Exhibition Center
513 Yeongdong-daero
Seoul, South Korea
Language
English
We are excited to announce our participation in Korea International Medical & Hospital Equipment Show (KIMES) 2025, the largest platform for medical professionals and buyers to explore the latest medical technologies event, taking place from March 20-23 in Seoul, Korea.
Visit our booth #D-248 to meet our team of experts
We at Emergo by UL are aware of the complicated issues that the medical device sector must contend with due to regulatory restrictions, and we have built our solutions with these issues in mind. For one or more products, we create specialized regulatory plans that might assist you in extending your global market reach. Visit our booth #D-248 to meet our team of experts and discover how we can support you by navigating the complex regulatory landscape.
Regulatory seminars
We will be holding seminars on specific topics to address your toughest challenges and provide tailored solutions for your regulatory needs. The location for all our seminars is: Room 315.
Brazil & Mexico – Medical Device Regulation
Time: 10:30 a.m. -12:00 p.m.
In this seminar we will examine current medical device registration requirements in Brazil and Mexico, recent regulatory changes, and current ANVISA and COFEPRIS registration and requirements.
Japan PMDA & US FDA - Pre-submission
Time: 13:00 p.m. – 14:00 p.m
This seminar helps attendees gain a deeper understanding of the Pre-Submission Consultation Program in the USA and Japan.
Complying with FDA QSR & QMSR
Time: 14:10 p.m. – 15:50 p.m
This seminar will provide an introduction to the FDA Quality System Regulation (QSR) and the Quality Management System Regulation (QMSR) Final Rule and include some inputs for complying with the FDA QSR and QMSR requirements plan.
Develop HF strategy to meet FDA requirement
Time: 16:00 p.m. – 17:00 p.m
This seminar will provide practical insights and actionable guidance on developing a human factor engineering (HFE) strategy to meet FDA requirements for medical devices. Participants will learn how to align usability engineering processes with regulatory expectations, including identifying critical tasks, conducting formative and summative usability testing, and integrating HFE with risk management.