Customized Human Factors Training for Your Development Teams
Tailor human factors training to your medical device development and production teams.
MHRA Publishes Guidance on Updated Schema for Incident and FSCA Reports in MORE
Great Britain’s medical device regulator unveiled new guidance outlining the implementation of new manufacturer incident (MIR) and field safety corrective action (FSCA) report XML schema definitions (XSD) for Great Britain for the Manufacturer’s Online Reporting Environment (MORE) reporting system.
Formative Usability Testing for Medical Devices
Discover how formative usability testing from Emergo by UL helps medical device manufacturers uncover user challenges early, refine designs and build safer, more effective healthcare products.
AI Literacy Per the European AI Act
As medical device manufacturers increasingly integrate AI technologies, the responsibility to confirm staff and end users possess adequate AI literacy is no longer optional. Understand what you need to know about AI literacy laws.
Swissmedic releases new guidance and adopts the updated EU MIR form
Our regulatory experts bring you up to speed on the European Commission release of a new help text file with information for completing the Manufacturer Incident Report (MIR) form.
Human Factors Validation Testing/Summative Usability Testing
Summative usability testing with Emergo by UL — trusted human factors validation testing expertise to support FDA compliance.
Documentation for Human Factors Validation Tests
Is your human factors validation testing documentation compliant? Learn about key components, including risk analysis, protocols and test reports.
European Commission Releases New Manufacturer Incident Report Form and Help Text
Read our regulatory experts’ timely summary of this latest medical device regulatory development from the European Commission
Substituting proxy participants for actual intended users in human factors validation testing
An Emergo by UL Human Factors Specialist discusses when it is acceptable to include proxy (surrogate) participants in HF validation testing, the FDA’s perspective on proxy participants and additional considerations to keep in mind when recruiting proxy participants.