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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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.
Our experienced staff and global network provide the life sciences and healthcare industry expertise you need to grow your businesses and bring industry-changing solutions to the market.
The medical device regulatory landscape is evolving. Our medical device regulatory consultants help you bring safer products to markets worldwide and maintain compliance — even if your device is novel or high-risk.
Tech companies are bringing consumer-oriented connected health solutions to the regulated device market. We help tech firms design, implement and run quality and risk management, clinical research, usability studies and more.
The demand for combination products continues to grow. We partner with combination product developers to overcome regulatory challenges as well as design safer, more effective products that help deliver more personalized and precise care.
Providers are under pressure to embrace tech-based delivery models that make care more accessible but introduce new risks. Our goal is to make life easier for providers and patients by focusing on the core challenges in the evolving state of care.
More health and wellness retailers are investing in branded medical devices and technologies that make healthcare more affordable and accessible. We help them understand and meet the unique regulatory obligations of the healthcare and device spaces.
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, including Product Classification and seven Smart Builders, that deliver critical assistance to companies transitioning to new regulatory schemes.
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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.
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Get the latest global medical device product development and regulatory news, insights and resources from our RADAR and TalkingPoints newsletters.
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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