Emergo by UL specializes in enhancing medical device usability through a comprehensive suite of services focused on human factors research and design. Their team of experts employs a holistic approach that includes user research, analysis, design, evaluation, and testing to ensure that medical products are not only effective but also user-friendly. By leveraging their extensive knowledge of regulatory standards and user needs, Emergo by UL helps clients navigate the complexities of product development and compliance, ultimately aiming to improve patient safety and satisfaction.

In addition to their consulting services, Emergo by UL offers innovative digital solutions such as the Optimal Product Usability Suite (OPUS™) and the Regulatory Affairs Management Suite (RAMS®). OPUS™ provides tools, templates, and training to streamline human factors engineering activities, while RAMS® simplifies the medical device classification process, allowing companies to efficiently determine their regulatory pathways. These technologies are designed to support medical device manufacturers in achieving compliance and market success, thereby fostering the development of safer and more effective healthcare solutions.

United States

Emergo provides quality and regulatory compliance consulting to medical device and IVD companies. We assist with medical device registration/approval, regulatory strategy, ISO 13485 and QMS compliance, local in-country representation and post market surveillance in 20+ markets worldwide. Offices in North America, South America, Europe, Asia, Australia and the Middle East.

Medical Device Usability

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