Human Factors Engineering for IVD Regulation (IVDR) Compliance in Europe
This webinar explains how IVD manufacturers can use human factors engineering (HFE) in Europe and the EU to meet In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements.
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.
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.
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
Learn from our team of human factors experts how to identify and mitigate use-related risk throughout the product development process.
TalkingPoints: Human Factors and Usability of Medical Device News
Our TalkingPoints newsletter is your source of information for human factors (hf) and the usability of medical devices, IVDs and combination products.
Update: Check First with FDA Regarding Their Current Availability to Review a Human Factors Validation Test Protocol
Recommendations for manufacturers seeking test protocol reviews as FDA deals with 510(k) backlogs