On-Demand Webinars

MDR and Human Factors – Get Ready for Transition

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.

Latest FDA Expectations for Conducting Human Factors Validation Tests of Combination Products

FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents.

Conducting Safe In-person Testing During COVID-19

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.

ISO 14971:2019 and the Current State of Risk Management

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.

PMS & PMCF Under the European MDR

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.

Extended MDR Date of Application: Optimizing Your PMS and Clinical Activities

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.

Clinical Evaluation Reports (CER) for Medical Devices

This webinar provides an overview of manufacturer responsibilities for clinical evaluation under the MDR. The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR).

Preparing for the EU MDR Date of Application

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?

NMPA Expectations for Applying Human Factors Engineering (HFE) to Medical Devices

During the webinar, the presenters will cover key HFE considerations when marketing medical devices in China, US and Europe.

The Role of Hardware User Interface Design in Medical Devices

Designers from Emergo by UL’s Human Factors Research & Design (HFR&D) team share tips and insights about the importance of hardware user interfaces.

Graphical User Interface Design for Medical Devices

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.

Applying Human Factors Engineering (HFE) to In Vitro Diagnostic (IVD) Products Under the European IVD Regulation (IVDR)

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 MDR and Human Factors Engineering (HFE) Requirements for Post-Market Surveillance (PMS)

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.

Person presenting to a conference room full of people

Developing Effective Training to Enhance and Support Internal HFE Resources

Learn about principles for developing training and resources to support the effective application of human factors engineering (HFE) to medical product development.

Nurse aligning a patient in order to take an x-ray

Conducting Usability Tests in China for NMPA: An Overview of Considerations Based on Past Learnings

Learn how the NMPA’s HFE guidelines impact HFE work and the best ways to plan and conduct usability tests in China for NMPA.

Human Factors Engineering for Medical Devices

Twenty years after FDA first called upon manufacturers to apply human factors engineering (HFE) in medical device development, HFE has become a relatively mainstream activity.

Applying Human Factors and Usability Engineering to Medical Devices (GERMAN) - Part I

Emergo by UL offers a wide range of services to medical device developers, including human factors engineering and design services.

Meeting FDA Expectations for Human Factors Engineering Activities

FDA has provided industry with guidance on how to apply human factors engineering (HFE) to the development of medical technology.

An Intensive Look at Methods for Identifying Potential Use Errors

To support safe and effective use of medical device and combination products, it is incumbent upon manufacturers to identify and mitigate use-related risks during product development.

Medical Device Registration - Mexico Updates

In this complimentary webinar, we will examine current medical device registration requirements in Mexico and recent regulatory changes.