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TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.
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New laws will enable manufacturers to leverage their FDA registrations for Swiss market access
New and upgraded learning management and training features to support pharmaceutical, medical device and biotechnology companies
How to approach software bug issues in the context of human factors validation and usability studies.
Recommendations for designing user-friendly electronic medical records for use by healthcare providers and clinicians.
Final FDA guidance on Unique Device Identifier (UDI) rules for medical devices and stand-alone software comes several years after draft guidance issued. Learn more at Emergo by UL.
A look at how high-quality instructions for use drive positive user experiences with at-home COVID-19 and related testing. Learn more at Emergo by UL's Human Factors Research & Design.
Emergo by UL's Human Factors Research & Design team provides recommendations for when manufacturers make changes to the designs of their medical devices.
Our Human Factors Research & Design (HFR&D) team summarizes highlights from this year's Human Factors in ergonomics in healthcare symposium. Learn more at Emergo by UL.
Smart medical devices and healthcare products require sound HFE and usability principles for design. Learn more at Emergo by UL's Human Factors Research & Design.
The rise of standard operating procedures and more methodical application of HFE for medical devices can be supported through digital resources and tools.
Our Human Factors Research & Design team discusses standard sketching techniques to develop essential device design features and components.
A look at how innovative user interface design of medical devices and technologies can yield safer, more effective experiences for patients and users. Learn more at Emergo by UL's Human Factors Research & Design.
The FDA reports cybersecurity threats found in some software components require medical device makers to take prompt action.
Final guidance from US FDA covers how manufacturers and distributors should develop and initiate voluntary recalls of products including medical devices, IVDs and pharmaceuticals. Learn more at Emergo by UL.
US FDA has provided answers to Frequently Asked Questions regarding planned harmonization of 21 CFR Part 820 quality management system requirements with the ISO 13485 standard.
Emergo by UL, a global medical device and healthcare technology consultancy, has launched a web-based platform, Optimal Product Usability Suite™ (OPUS).
OPUS™ digital access to human factors engineering (HFE) tools to enhance medical product safety, effectiveness and ease of use. Learn more at Emergo by UL Human Factors Research & Design.
US FDA provides communication timeline for 510(k) reviews in accordance with MDUFA III performance goals.
FDA guidance outlines appeal options for medical device industry stakeholders disputing regulatory decisions and actions by the Center for Devices and Radiological Health (CDRH). Learn more at Emergo by UL.
Proposed rule from US Food and Drug Administration harmonizes 21 CF Part 820 to ISO 13485 quality management system standard for medical devices.
