Emergo by UL

Two weeks left! FDA expectations are evolving. Your submission strategy should too. Get a clear breakdown of the new human factors guidance, including submission categories and validation requirements. Save your spot now and avoid registration delays: https://s.ul.com/4gMyRhW #MedTechIndustry #MedTech #FDACompliance #HumanFactorsEngineering #MedicalDevices

Starting a use-related risk analysis can feel complex, but leading medical device manufacturers are evolving how they approach it. From early task understanding to smarter use of real-world data, the imperative is clear. A strong foundation shapes everything that follows. Watch how experts are rethinking URRA from the start. #MedicalDevice #MedTech #Usability #HFEConsulting #HumanFactors #ProductDevelopment #URRA #UsabilityEngineering

The FDA’s 2026 Human Factors guidance is here. Are you ready? Learn what changed, what it means and how to adapt your submission strategy before enforcement begins in August. Join our webinar on July 28, and stay ahead. Register today: https://s.ul.com/4wgXrMD #MedicalDevices #HumanFactors #FDA #ProductDevelopment #RegulatoryAffairs #MedTech #LifeSciences

Health Canada: Update on Phase 2 to Modernize Medical Device Establishment Licensing (MDEL) In November 2025, Health Canada published in the Canada Gazette, Part I, Volume 159, Number 45: Regulations Amending the Medical Devices Regulations (Establishment Licenses), its proposal to modernize the regulatory framework for Medical Device Establishment Licensing (MDEL). Read more: https://s.ul.com/4gBJ7JR

Regulatory reliance authorizations: Brazil’s revised ANVISA process June 2026 Emergo by UL experts highlight recent regulatory reliance authorizations under IN 290/2024, demonstrating evolution in Brazil’s ANVISA review approach. Read more: https://s.ul.com/4oJJft2

Final reminder — Emergo by UL webinar tomorrow! Join us June 16, 2026 from 10-11 a.m. (CST) for part two of our webinar series on unique device identification (UDI) and EUDAMED European Database on Medical Devices (EUDAMED) to get a clear view of how UDI requirements are evolving across global markets. We'll cover current expectations, reporting databases and why keeping a close watch onmarket-specific changes is essential for compliance. RSVP now for access! https://s.ul.com/4dXJgFH #MedicalDevices #EUDAMED #EUMarketAccess #MedicalDevices #RegulatoryStrategy #UDI #ComplianceMatters #UDICompliance #MedDeviceRegulations

Update on Japan Cabinet Order No. 362 and MHLW Notification No. 0331-20 and U.S. FDA authorized devices as equivalent Emergo by UL experts provide an update on Japan Cabinet Order No. 362 and MHLW Notification No. 0331-20 and U.S. FDA-authorized devices as equivalent. Learn more: https://s.ul.com/4aGkpUQ

U.S. FDA updates to eSTAR (version 7.0) and PreSTAR (version 3.0) On June 1, 2026, the U.S. Food and Drug Administration (FDA) released new major versions for both eSTAR templates (version 7.0) and the PreSTAR template (version 3.0). These are major revisions to the templates, meaning that after a transition period, the FDA expects all new submissions to be made using these versions of the templates. Read more: https://s.ul.com/440gU84

Second set of frequently asked questions about EUDAMED: scope During our recent EUDAMED webinar. there were a tremendous number of questions. For your convenience, we’ve compiled the second set of questions in a Q&A format. This one focuses on scope. Learn more: https://s.ul.com/4oqDL6p

First set of EUDAMED frequently asked questions: deadlines During our recent EUDAMED webinar, there were a tremendous number of questions about EUDAMED. For your convenience, we’ve compiled the questions here in a Q&A format. This first part of our series focuses on deadlines. Read more: https://s.ul.com/4o6MeLu