Human Factors Engineering Consulting for Medical Devices
Discover how human factors engineering consulting services from Emergo by UL support medical device development through expert guidance, training, and regulatory strategy.
UK Medical Device Regulators Remove Revocation Dates for Assimilated EU Laws
Our regulatory experts update you on the MHRA publishing the UK Statutory Instrument No. 591, which is intended to remove the revocation dates of four pieces of assimilated EU law.
Is Institutional Review Board (IRB) Approval Necessary for Usability Tests?
Learn when and why IRB approval is necessary for usability tests in medical device development, including regulatory requirements and risk considerations.
Search Functions in the European Medical Device Database EUDAMED
As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports on medical device searches in the European database for medical devices, EUDAMED, with the device registration data that has already voluntarily been included.
FDA Expands 510(k) Premarket Notification Database to Include New Sub-Categories to Enhance Search Capabilities
The FDA has added six new subcategories to make it easier for users of the 510(k) Premarket Notification Database to search for cleared medical devices.
Open Forum: Usability Testing Q&A
Our senior HFE experts will answer your pre-submitted and live questions on conducting usability testing of medical devices during this interactive session.
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.