Emergo by UL is a leading consulting firm specializing in global regulatory compliance and human factors for products in the medical industry. Our comprehensive services are designed to help you achieve and maintain regulatory and commercial success.
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Our experienced staff and global network provide the support you need in the healthcare industry to grow your businesses and bring industry-changing solutions to the market.
From discovering your users’ needs to navigating post-market compliance, partner with Emergo by UL. Our medical device regulatory consultants and human factors experts in more than 20 countries can help you improve your medical device designs, guide you through global regulations, and prioritize markets for new product growth.
Apply human factors throughout your product development process to meet users’ needs and global regulators’ expectations. Learn more.
Utilize our years of hands-on experience to help you get your products to market as efficiently as possible. We help compile, submit, and manage all of your device registrations. Learn more.
Bring our design expertise into your software, hardware, and instructional development to create great user experiences while reducing harmful use errors. Learn more.
Leverage our local presence and regulatory expertise by appointing Emergo as your independent in-country representative and maintaining control of your medical device registrations. Learn more.
Generate insights to enhance device usability and use-safety with formative and HF validation (summative) testing, expert critiques, heuristic analyses and cognitive walkthroughs. Learn more.
Leverage our expertise to solve complex regulatory challenges. We design a regulatory and QMS strategy that takes your product to established and emerging markets worldwide. Learn more.
Maintain your market position with post-market surveillance and vigilance, root cause analysis, incident reporting, and global vigilance support. Learn more.
Work with our experts to understand and navigate specific requirements you will need to comply with to bring your product efficiently to market. Learn more.
Software tools and regulatory intelligence to optimize your product development, compliance and risk management processes.
Manage your global medical device registration and compliance efforts with our Regulatory Affairs Management Suite (RAMS). Developed by experts at Emergo by UL, RAMS offers a growing portfolio of EU MDD, MDR, and IVDR services.
Empower your team with digital Human Factors Engineering (HFE) expertise. Emergo by UL’s Optimal Product Usability Suite (OPUS™), leverages training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.
Our resource centers for Europe, Asia and Latin America compile regulatory updates and insights, white papers, process charts, videos, and available medical device consulting services for fast access to region-specific market and regulatory information.
Europe's Medical Devices Regulation (MDR) went into force in May 2021, requiring action. Meet our MDR team and get complimentary educational resources on the MDR to help you comply with this new regulation.
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Europe’s In Vitro Diagnostic Devices Regulation (IVDR) brings big changes, so it is imperative to prepare yourself. Meet our IVDR experts and find related news and resources.
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Explore the medical device and IVD regulatory systems of Brazil and Mexico, and access growing markets throughout the region. Find out how we can help you expand your global footprint.
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The nations of Asia can be profitable targets for medical devices and in-vitro diagnostic device manufacturers hoping to expand their commercial reach. Navigate each market in Asia confidently with Emergo by UL’s global regulatory affairs expertise and local support.
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