Human factors considerations for medical devices used by older adults In this article focused on medical device design, we explore the current landscape of how older adult users might interact with technology, particularly those in the healthcare space. Learn more here: https://s.ul.com/4gfCY3p #medicaldevice #regulatory #regulatorycompliance #humanfactors #insight #medicalproducts
About us
Emergo provides quality and regulatory compliance consulting to medical device and IVD companies. We assist with medical device registration/approval, regulatory strategy, ISO 13485 and QMS compliance, local in-country representation and post market surveillance in 20+ markets worldwide. Offices in North America, South America, Europe, Asia, Australia and the Middle East.
- Website
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http://www.EmergobyUL.com
External link for Emergo by UL
- Industry
- Professional Services
- Company size
- 201-500 employees
- Headquarters
- Austin, TX
- Type
- Privately Held
- Specialties
- Regulatory strategy and consulting, QMS implementation and audits, Medical device and IVD registation, Clinical data evaluation and PMCF, In-country regulatory representation, and Post market surveillance consulting
Locations
Employees at Emergo by UL
Updates
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Join us live on Sept. 18, 2024, from 9-9:45 a.m. CST, for an insightful session with our subject matter experts, Cory Costantino and Alix Dorfman, from Emergo by UL’s Human Factors Research & Design team, to discover how use-related risk analysis can transform your development process. Throughout this presentation, Cory and Alix will show how use-related risk analysis can: • Access the heart of medical device product development • Be a partner in creative thinking by organizing what can go wrong Register today: https://s.ul.com/4g7wHHh #regulatory #risk #analysis #webinar #medicaldevices #testing #medtech #humanfactors #devices
Risk Analysis for Design and Innovation
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Only two weeks until #RAPS2024 and you won’t want to miss it! 🙌 ⏩ Stop by our booth #739 to meet our experts, who leverage more than 22 years of #regulatory experience. Plus, we will be presenting at the Spark Theatre on the 18th at 3:30 pm on Navigating and Managing the Global Regulatory Landscape: Strategic Approaches for Success. You’ll also get an exclusive look at our Regulatory Affairs Management Suite (RAMS) digital platform, which enables regulatory research and more. 🗓️ Schedule a meeting with our experts here: https://s.ul.com/3WKH2kI
RAPS Convergence 2024
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U.S. FDA announces De Novo final guidance and eSTAR implementation date The FDA issued the Final Rule (FR Doc. 2024-18983) and Final Guidance on the Electronic Submission Template for De Novo (FDA-2023-D-3788) on Aug. 23, 2024. Within the final guidance, the FDA announced that eSTAR would be compulsory for De Novos, beginning Oct. 1, 2025. Learn more here: https://s.ul.com/3XotGL5 #medicaldevice #regulatory #regulatorycompliance #FDA #update #denovo
US FDA Announces De Novo Final Guidance and eSTAR Implementation Date
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Japan regulators MHLW/PMDA require compliance with HFE/UE standard The Japanese regulatory authorities, the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Products Agency (PMDA), require compliance with JIS T 62366-1:2022, Japan’s national Human Factors Engineering (HFE)/Usability Engineering (UE) standard for medical devices. Medical device manufacturers can learn more in our latest insights article: https://s.ul.com/4cKTjKD #medicaldevice #regulatory #regulatorycompliance #Japan #update #medicalproducts
Japan regulators MHLW/PMDA require compliance with HFE/UE standard
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Thailand FDA makes changes to acceptable documentation for medical device registration Thailand’s medical device regulator has released the list of regulators and agencies it will accept. The list includes the former Global Harmonization Task Force (GHTF) founding members, the World Health Organization (WHO), and the Singapore Health Sciences Authority (HSA). Learn more here: https://s.ul.com/472J7Mh #medicaldevice #regulatory #regulatorycompliance #Thailand #update #medicalproducts
Thailand FDA Makes Changes to Acceptable Documentation for Medical Device Registration
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Trying to get U.S. FDA clearance for your medical device or IVD? Download our step-by-step guide to help you navigate the U.S. Food and Drug Administration’s approval process per device classification. What’s inside: • Detailed, step-by-step guidance • Easy-to-understand 510(k) approval flowchart • Pro insights and regulatory strategies Get your first chart for free when you create a RAMS account. Learn more: https://s.ul.com/46sy0vG #medicaldevice #regulatoryaffairs #FDA #Processchart #US #medtech #healthtech #biotech
Comprehensive Guide to FDA Clearance for Your Medical and IVD Device
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We’re thrilled to share that our human factors experts Petra Boeree, Layne Hartman, and Katelynn Larson have been featured in the 2024 Pharmaceutical Manufacturing and Packing Sourcer, Parenteral Technology Supplement by Samedan Ltd. Explore the most recent global regulations and gain insights on how they could potentially impact your human factors engineering submissions in our latest feature here: https://s.ul.com/3M2iddJ For more information on how we can support your organization, visit our website: https://s.ul.com/3YC4DFu #medicaldevice #regulatory #update #humanfactors #submissions #developments
Human Factors Research & Design
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Check out Emergo by UL’s Allison Strochlic, the senior research director on our human factors team. In this podcast with Mouser Electronics, she discusses the newest technologies and developments in human-machine interfaces and human factors engineering. Link to the full podcast: https://s.ul.com/475vP1y. Discover how our HFR&D experts can help you design and evaluate products that meets user's needs here:: https://s.ul.com/475vPyA #medicaldevice #regulatory #design #podcast #usability #interface #humanfactors
Human Factors Research & Design
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The South Korea Ministry of Food and Drug Safety (MFDS) has set a new milestone with the implementation of the latest Unique Device Identifier (UDI) requirements. First issued on December 21, 2018, Unique Device Identifier (UDI) requirements (MFDS notification No. 2018-109) are now officially part of Article 20 of the Medical Device Act (No. 19655) and Article 54-3 of the Enforcement Regulations of the Medical Device Act (No.1946), culminating in the current rule, MFDS notification No. 2023-67, which makes UDI compliance mandatory for all devices. Curious about what this means for your medical device or IVD products? Read our latest white paper, Introduction to South Korea’s Medical Device UDI System, written by Emergo by UL’s Lead Quality and Regulatory Affairs Consultant, JAE YEONG NOH, to help your team prepare for these important changes. What’s inside: • Learn the basics of this new regulation • Critical points to consider • Preparation strategies to support a smooth UDI system implementation Download now: https://s.ul.com/3T9PMhV #medicaldevice #regulatoryaffairs #regulatory #whitepaper #medtech #vigilance #reporting
Introduction to South Korea’s Medical Device UDI System
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