Certificate of registration: ISO 13485:2016
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이머고는 귀사의 글로벌 의료기기 규제준수 파트너입니다.
Emergo by UL은 글로벌 의료기기와 IVD 규제준수를 전문으로 하는 선도적인 인허가 컨설팅 기업입니다. 종합적인 솔루션으로 인허가 및 상업적인 성공을 달성하고 유지하는 것을 도와드립니다. 6개 대륙에 위치한 사무소를 통해, 실시간 서비스와 현장 전문가를 제공해 드립니다. 귀사를 발전시킬 수 있는 이머고의 지원 서비스를 확인해보세요.
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.