We Specialize in Global Medical Device Compliance and Innovation
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.
The healthcare and life science industries are changing, and we have the breadth of expertise to help you evolve with them.
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.
Health and wellness retail
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.
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, including Product Classification and seven Smart Builders, that deliver critical assistance to companies transitioning to new regulatory schemes.
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.
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.