Conducting risk assessments for medical devices
About this course
Use errors associated with medical devices can lead to patient injuries or even deaths. Reducing that risk is one goal of regulatory requirements for manufacturers to perform HFE activities that focus on their products’ safety and effectiveness.
This course covers one of the most important activities aimed at enabling manufacturers to make safer and more effective medical devices: risk analysis, and specifically use-related risk analysis. Upon completion of this course, you will be able to: (1) explain the relationship between risk and safety, (2) describe the fundamental risk management process, (3) explain the differences between conventional risk analysis and use-related risk analysis, and (4) explain how to identify, analyze, and mitigate against use-related risks.
Number of courses
Emergo by UL’s new cloud-based human factors engineering (HFE) platform, Optimal Product Usability Suite (OPUS™), leverages training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.
Sign up for courses on our HFE software platform, OPUS.