Emergo has been helping medical device and IVD companies with regulatory compliance and market entry since 1997. We maintain offices in 25+ countries, offering a wide range of compliance services, including regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation.
Human Factors Research & Design
Human factors examines the relationship between human beings and the systems they use, focusing on improving effectiveness and ease of use with the goal of minimizing use errors. Our consulting team has deep experience in the medical device and combination product domains.
Privacy & Security Services
Emergo by UL's data privacy team has extensive experience in helping medical device and in-vitro diagnostic manufacturers navigate patient privacy regulatory requirements for global markets. We have in-depth expertise with US and European data privacy requirements and can help you address manufacturer needs for a range of connected devices