The new Great Britain vigilance report schema goes live
On Monday, June 16, 2025, the new Great Britain vigilance report schema goes live in alignment with the timing of the new post-market surveillance regulations coming into force.
Early Design Evaluations for Medical Devices
Emergo by UL helps medical device developers optimize early-stage design with expert critiques, user walkthroughs and human factors evaluations.
Mexican Regulator COFEPRIS Revises Equivalency Route to Expand Leveraging Options
To evaluate health supply registrations, Mexico’s COFEPRIS released a new agreement for the equivalency requirements established by the Health Supplies Regulations.
Brazil Regulatory Updates
Join our regulatory experts for a focused discussion on Brazil’s evolving medical device regulatory landscape, covering developments in device registration, IVD regulations and UDI compliance.
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.