Certificate of registration: ISO 13485:2016
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 in order to get products to market faster.
Comprehensive RA/QA solutions
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. We also partner with Greenlight Guru for electronic quality management system ComplianceWire™ from UL Solutions for electronic learning management solutions.
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.
Helping Customers Create Great Products
Emergo by UL’s Human Factors Research & Design team has extensive experience helping clients bring products to market and ensuring best-in-class user experiences. We view ourselves as part of the solution for making healthcare safer and more effective while also helping clients achieve their commercial goals.
UL Solutions acquired Wiklund Research & Design in 2012. In mid-2018, UL acquired Medical Device Usability. The two consulting groups are now fully integrated with offices in North America, Europe and Asia to deliver services to an international clientele.
In 2022, the HFRD team introduced Optimal Product Usability Suite (OPUS™), human factors software, which provides training, tools, and resources needed to get your medical devices to market quickly.