Your partner for medical device, in-vitro diagnostic regulatory affairs management
Emergo was founded in 1997 with a mission to help medical device and IVD manufacturers manage regulatory affairs compliance and expand into new markets. We have grown into a global solutions provider specializing in end-to-end regulatory affairs/quality assurance life cycle management. Our unique services include local project managers and local sales teams partnering with global RA/QA experts for product lifecycle management.
In 2017, UL Solutions acquired Emergo. UL Solutions’ depth and breadth of nonclinical testing expertise complements Emergo’s global device registration, quality management, in-country representation, and related services. By joining the UL enterprise, Emergo can offer customers more comprehensive support for medical device registration, QMS compliance and now, nonclinical testing and certification to get products to market faster.
Enabling innovation, compliance and safety
The healthcare and life science industries are changing, and we have the breadth of expertise to help you evolve with them.
Pharmaceuticals/BioTech
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.
MedTech
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.
HealthTech
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.
Healthcare providers
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.
Comprehensive regulatory affairs and quality assurance solutions
Helping customers create great products
Emergo by UL’s Human Factors Research & Design team has extensive experience helping clients bring products to market and supporting best-in-class user experiences. UL Solutions acquired Wiklund Research & Design in 2012. In mid-2018, UL acquired Medical Device Usability. The two consulting groups are now fully integrated into our offices in North America, Europe, and Asia to deliver services to an international clientele.
In 2022, our HFR&D team introduced Optimal Product Usability Suite (OPUS™), human factors software, which provides the training, tools and resources needed to get your medical devices to market quickly.
Total market access solutions provider
Emergo by UL’s Market Access team maintains offices in more than 25 global locations. In addition to an extensive network of medical device and IVD RA/QA experts, we partner with key industry professionals, including MedEnvoy for European representation services.
Emergo launched Regulatory Affairs Management Suite (RAMS®) in 2019. RAMS has quickly become a go-to SaaS solution to complement traditional RA/QA consulting services.
Emergo by UL is an ISO 13485-certified company that offers services globally. The certification scope covers the Medical Market Access services and offices listed on the certificate. This excludes any services provided by Emergo by UL’s Human Factors Research and Design (HFR&D) team.
Emergo by UL在全球各地设有办事处并拥有合作伙伴
Emergo by UL在全球各地设有办事处并拥有合作伙伴Emergo by UL于全球六大洲设有当地办事处，所有办事处均配备当地法规团队，我们的法规专家充分掌握针对各自国家独特监管要求的合规专业知识。
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