Emergo by UL

With Emergo by UL, you have a single independent consultant acting as your global representative for your registrations worldwide. Let our expert team guide you through regulatory compliance in the U.S,. EU, Asia and beyond. Why you can rely on us: - In-Country Experts: Support for local regulatory requirements. - Simplified Expansion: Faster approvals across multiple regions. - Global Network: Expert representation in key markets worldwide. Find out how we make market access easier: https://s.ul.com/4h8Y1oo #Regulatoryaffairs #Medtech #compliance #global #representation #strategy #Marketaccess #MedicalDevices #expansion #Asia #US #EU

Are you in KIMES? Come by and visit us in booth # D-248, and discover how we can help you overcome complex medical device regulations. We are more than happy to answer all your queries regarding global medical device and IVD compliance and how we can support you at every step of the way. #KIMES2025 #Regulatory #tradeshow #Regulatoryaffairs #medtech #healthtech #medicaldevices

Human factors engineering: Where empathy meets innovation. Usability evaluations can uncover insights that help make medical products safer and more intuitive for end users. How Emergo by UL can help your team: • Safety-focused user evaluations • Real-world feedback, practical improvements • Optimize design and user satisfaction Learn more: https://s.ul.com/3EifX1m #training #consulting #medicaldevices #regulatorycompliance #humanfactors #usability

Last chance to register for our webinar on EU AIA and the interplay with the EU MDR/IVDR, tomorrow March, 20th 2025. Our Emergo by UL expert, Sade Sobande will explain more about the EU AI Act process. In this webinar, you will: - Understand MDR/IVDR implications. - Learn how AI systems will be classified. - Get expert insights on risk and compliance. Register Today: https://s.ul.com/40Rxy7W #regulatory #regulatorycompliance #webinar #medicaldevices #medtech #IVDR #MDR #AI #EUregulatoryaffairs

User safety is non-negotiable. Utilize our global team of human factors engineering experts to help you optimize usability and demonstrate that your medical devices meet compliance standards. Streamline your success: • Quicker regulatory approvals • User-focused, safer designs • Reduce risks through compliance Contact us: https://s.ul.com/40R9S4W #productevaluation #design #medicaldevices #regulatorycompliance #humanfactors #research

South Korea’s Ministry of Food and Drug Safety (MFDS) registration doesn’t have to be complicated. Emergo by UL’s local experts will facilitate a seamless approval process. Why choose us? - Independent in-country representation to meet MFDS requirements. - Expertise in device classification and risk management strategies to avoid delays. - Proven success in the South Korean market. Simplify your MFDS approval: https://s.ul.com/4gp93oA #Regulatoryaffairs #Medtech #compliance #global #representation #strategy #Marketaccess #MedicalDevices #expansion #Asia #MFDS #Korea

Health Canada continues to monitor medical device supply In Canada, the Minister of Health at Health Canada continues to add and remove devices deemed “shortages.” Here, we report on how that is working. Learn more here: https://s.ul.com/4itR4yN #medicaldevice #regulatoryupdate #Canada #Health #regulatory #compliance

IMDRF updates terminologies for categorized adverse event reporting The IMDRF has updated the technical document that defines the categories for adverse event reporting for medical devices. Learn more here: https://s.ul.com/3RaSP88 #medicaldevice #regulatoryupdate #vigilance #postmarket #surveillance #regulatorycompliance #compliance

MHRA publishes consultation outcome on statutory fees The Medicines and Healthcare products Regulatory Agency held a public consultation on proposed amendments to statutory fees. Learn more about the outcome and its impact on the U.K. market here: https://s.ul.com/4ks991M #medicaldevice #regulatoryupdate #EU #MHRA #europeancommission

Expanding to new medical device markets doesn’t have to be complicated. With Emergo by UL’s global network and expertise, you have a single independent in-country representative provider for all your registrations worldwide. We help you navigate regulatory requirements across multiple regions, so you can focus on growing your business. Ready to take your product global in 2025? Learn how we can support your global expansion: https://s.ul.com/3PPFgdM #Regulatoryaffairs #regulatory #Medtech #compliance #independent #representation #strategy #Marketaccess #MedicalDevices #expansion