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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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As medical devices adopt more advanced technologies, their reliance on software has been increasing.
The transition period from MDD to MDR comes to an end on May 26th, 2021. Among the many regulatory changes, the role of human factors is greatly enhanced.
FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents.
The experts from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights learned from creating a safe setting to conduct in-person testing in light of COVID-19.
This webinar is intended to highlight some of the key areas where the standard was changed technically, and where guidance was either introduced or expanded.
Many companies will need to maintain more robust PMS procedures and perform more PMCF studies to meet their Notified Body’s expectations. In this free webinar, we will discuss new European PMS and PMCF requirements.
In this one-hour webinar, we will focus on key compliance issues manufacturers should focus on in order to fully utilize the additional time granted before the MDR date of application.
The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR). This webinar provides an overview of manufacturer responsibilities for clinical evaluation under the MDR.
The EU medical devices regulation (MDR) date of application (DoA) is imminent. Do you understand what your regulatory obligations will be as of May 26, 2021?
During the webinar, the presenters will cover key HFE considerations when marketing medical devices in China, US and Europe.
Designers from Emergo by UL’s Human Factors Research & Design (HFR&D) team share tips and insights about the importance of hardware user interfaces.
Designers from Emergo by UL’s Human Factors Research & Design (HFR&D) team share tips and insights about the nuances of graphical user interface design for medical devices.
In this video we'll explore the different aspects of a CER including what it is, why it is needed, an overview of the research process, and finally its contents and formatting.
In this video we will learn more about the background of this global quality management system standard, and the steps you can take to obtain ISO 13485 certification in Europe.
Canada is a well-established but lucrative market for medical devices. This 4 minute video explains the medical device registration process in Canada, and the process for gaining approval from Health Canada.
The United States is the number one medical device market in the world. This 4 minute video explains the medical device registration process in the USA, and the process for gaining approval from the FDA.
Yvonne Limpens and Brenda van Geel from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the upcoming IVDR and its implications for HFE.
The EU Medical Devices Regulation (MDR) includes specific requirements for post-market surveillance (PMS), calling on medical device manufacturers to provide a detailed PMS plan in their submission.
Learn about principles for developing training and resources to support the effective application of human factors engineering (HFE) to medical product development.
Learn how the NMPA’s HFE guidelines impact HFE work and the best ways to plan and conduct usability tests in China for NMPA.