Emergo by UL

Navigating complex regulations for medical devices? Emergo by UL’s regulatory affairs services help you achieve compliance faster and more efficiently. Here’s how we help: - Customized strategies for global regulatory requirements. - Expertise in pre-market submissions and clinical evaluations. - Guidance for quality management systems and audits. - Support for regulatory intelligence and gap analysis. Explore our Regulatory Affairs services: https://s.ul.com/4aS5lTj #Regulatoryaffairs #audit #quality #consulting #compliance #global #strategy #Marketaccess #MedicalDevices

The Emergo by UL difference: Transforming complex usability challenges into actionable, compliance-driven steps. Our human factors experts can help medical device manufacturers: • Gain insights through feedback and evaluation • Reduce risks using proven methods • Meet regulatory and safety expectations Learn more: https://s.ul.com/3EiPUar #productdevelopment #challenges #medicaldevices #regulatorycompliance #humanfactors #combinationproducts #discovery

Japan’s Pharmaceuticals and Medical Devices Agency (PMSA) approval process can be complex. Emergo by UL makes it easier with tailored support for medical devices and IVDs. Here’s what we do to help you get into market: -In-depth guidance on PMSA regulations -Assistance with risk management and clinical evaluations - Proactive compliance support to avoid delays. Learn more here: https://s.ul.com/4jvERe3 #Regulatoryaffairs #Medtech #compliance #global #representation #strategy #Marketaccess #MedicalDevices #expansion #Japan #PMSA

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