Emergo by UL

Only two weeks until HFES 2025 and you won’t want to miss it! Stop by table #1 to meet our experts. At Emergo by UL, we’ve helped improve safety and usability for many medical devices, combination products, and SaMD. Don’t miss our: ? Day 1: Workshop at 1:30 p.m. – 5:30 p.m ? Day 2: Presentation and Panel at 1:30 – 2:00 p.m. and 3:30 p.m. – 4:30 p.m. ? Day 3: Presentation and Panel at 8:30 a.m. – 9:00 a.m. and 10:30 a.m. – 12:00 p.m. ? Day 4: Panel, Presentation at 8:30 a.m. – 9:00 a.m. and 11:00 a.m. – 11:30 a.m. Schedule a meeting with our experts here: https://s.ul.com/43HpycH Merrick Kossack Julee Harlow HenryLayne Hartman Suruchi Batra Michael Wiklund Allison Strochlic Laura Birmingham Erin Davis Yong Sun Michael Orduz Rachel Aronchick Mark Tavano Austin Cournoyer #HFES #Medicaldevice #Regulatoryaffairs #software #experts #medicaldevices

From usability testing to risk mitigation, our experts guide you through every stage of product development. Our goal is to support your efforts in adhering to safety objectives and navigating the regulatory landscape effectively. Why leading medical device and IVD companies trust Emergo by UL for human factors expertise: ? Guidance from concept to launch ? Optimized market entry processes ? Help with user-centric, safety-driven design Explore our services: https://s.ul.com/4hhTq3m #product #design #medicaldevices #regulatorycompliance #humanfactors #guidance #development #combinationproducts

High-risk AI in MedTech: What you need to know. Join us live on March 20th, 2025 from 9 – 9:45 am with our subject matter expert Sade Sobande from Emergo by UL to get ahead of the changes. The EU AI Act introduces new risk classifications, stricter compliance requirements, and enhanced data governance. How will it impact your AI-powered medical devices? We’ll break down: - How the EU AIA intersects with MDR/IVDR - What qualifies as a high-risk AI system - Key steps to support your regulatory approach. Secure your spot today: https://s.ul.com/4iaDT5F #regulatory #regulatorycompliance #webinar #medicaldevices #medtech #IVDR #MDR #AI #EUregulatoryaffairs

Last chance to secure your spot for our upcoming webinar with our experts, Yvonne Limpens and Julee Harlow Henry from Emergo by UL’s Human Factors Research & Design on March 12th, 2025 from 9:00 – 10:00 AM CST for an engaging session on Insights and expertise gained from a year of applying the 2024 HF guidance. Key takeaways from this webinar: ? Dive into the key requirements of the NMPA HF guidance ? Learn strategies to streamline your compliance efforts ? Hear practical insights from HF experts Register today: https://s.ul.com/3CMh4Gk #regulatory #humanfactors #medtech #guidance #NMPA #China #webinar

Simplify your compliance journey with Emergo by UL. Our regulatory affairs experts help you overcome challenges, reduce delays and achieve faster market entry. What we offer: - End-to-end support for global medical device regulations. - Expertise in pre- and post-market activities. - Customized compliance strategies for IVDs and medical devices. - Proven success in managing complex submissions. Explore our services: https://s.ul.com/4jvcBYV #Regulatoryaffairs #regulatory #Medtech #compliance #challenges #FDA #MDR #IVDR #NMPA #ANVISA #strategy #Marketaccess #MedicalDevices

The U.S. medical device market is one of the largest globally. Emergo by UL helps meet FDA requirements, so you can focus on innovation while we handle compliance. Here’s how we help: - Expertise in 510(k), and De Novo submissions. - Tailored strategies for IVDs and medical devices. - Comprehensive pre- and post-market compliance support. - 20+ years of FDA consulting experience. Start your FDA journey: https://s.ul.com/4hbVj1y #Regulatoryaffairs #Global #Medtech #FDA #US #strategy #Marketaccess #MedicalDevices #DeNovo #postmarket

Ready to expand into Europe’s medical device market? CE marking is essential for EU market access. Emergo by UL simplifies the process with 20+ years of expertise in EU MDR and IVDR compliance. Why work with us? - Expert guidance for technical and clinical documentation. - Strategies for faster CE marking approvals. - Independent authorized representation to meet EU requirements. - Proactive compliance support to avoid delays. Learn more here: https://s.ul.com/4jvXqij #Regulatoryaffairs #Global #Medtech #globalexpansion #MDR #IVDR #strategy #Marketaccess #MedicalDevices

Expanding globally? Regulatory challenges vary across regions. Emergo by UL simplifies the process with tailored support for each medical device market. Key benefits of our regulatory affairs services: - Expertise across areas such as U.S. FDA registration, CE marking, and Brazil ANVISA compliance. - Streamlined submissions to reduce approval timelines. - Guidance on global standards and compliance frameworks. - Ongoing support for post-market activities. Start your global journey to compliance: https://s.ul.com/40O7ufd #Regulatoryaffairs #Global #Medtech #FDA #US #strategy #Marketaccess #MedicalDevices

Discover how to meet NMPA’s 2024 HF guidance expectations and succeed in China’s growing market. Join our webinar on March 12th , 9:00 am-10:00am CST. Our subject matter experts, Yvonne Limpens and Julee Harlow Henry will discuss insights and expertise gained from a year of applying the 2024 HF guidance. Register Today: https://s.ul.com/41aQ0dd #regulatory #humanfactors #medtech #guidance #NMPA #China #webinar

Only two weeks until KIMES 2025 and you won’t want to miss it! Stop by our booth # D-248 to meet our experts leveraging more than decades of regulatory experience. Plus, you’ll get the chance to attend our seminars in room 315. 1. Topic: Brazil & Mexico – Medical Device Regulation - Introduction: 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. -Time: 10:30 a.m. -12:00 p.m. 2. Topic: Japan PMDA & US FDA - Pre-submission -Introduction: This seminar helps attendees gain a deeper understanding of the Pre-Submission Consultation Program in the USA and Japan. -Time: 1:00 p.m. – 2:00 p.m. 3. Topic: Complying with FDA QSR & QMSR -Introduction: This seminar will provide the introduction of FDA Quality System Regulation (QSR) and Quality Management System Regulation (QMSR) Final Rule. -Time: 14:10 p.m. – 15:50 p.m. 4. Topic: Develop HF strategy to meet FDA requirement -Introduction: This seminar will provide practical insights and actionable guidance on developing a human factor engineering (HFE) strategy to meet FDA requirements for medical devices. -Time: 16:00 p.m. – 17:00 p.m. See you there! https://s.ul.com/4i9u8nY #KIMES2025 #Regulatory #tradeshow #Regulatoryaffairs #medtech #healthtech #medicaldevices