China NMPA Human Factors Engineering Finalized Guidelines
In this on-demand webinar, our Emergo by UL subject matter experts share insights on how to navigate through the finalized China NMPA HFE guidelines.
Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices
Medical device regulator ANVISA published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for Brazil market access.
Brazil ANVISA Guidance for IVDs with Changed Risk Classification per RDC 830/2023
Detailed discussion about Brazil ANVISA guidance on IVDs with changed risk classification.
2024 HFES International Symposium on Human Factors and Ergonomics in Health Care Takeaways
Nearly 20 Emergo HFR&D team contributed nine presentations to the 2024 HFES International Symposium on Human Factors in Health Care, and mostly spent time in the Medical and Drug Delivery Devices (“MDDD”) track.
Third Annual European Medical Device Human Factors and Usability Engineering Conference
Emergo by UL will be at the third annual European Medical Device Human Factors Conference.
EU Recap: March 2024 was a Month of Many Medical Device Regulatory Updates
Manufacturers should commence their MDR and IVDR compliance journeys now. Emergo by UL recommends manufacturers review the guidance provided by their notified bodies as well as the Team NB Best Practice Guidance on the MDR Technical Documentation File (TDF) and similar guidance for the IVDR TDF.
Effective Date Nears for Brazil ANVISA IVD Regulation RDC 830/2023
Brazil’s medical device regulator ANVISA announced RDC 830/2023 becomes effective June 1, 2024, requiring manufacturers to assess gaps between RDC 36/2015 and RDC 830/2023, and review the classification of their IVDs.
Laboratory Developed Test Manufacturers in the U.S.
In this on-demand webinar, our Emergo by UL subject matter expert will share insights on how to navigate laboratory-developed test manufacturers in the U.S.
Webinar debrief: Applying Human Factors Engineering to Software as a Medical Device
On March 20, 2024, our Senior Research Director Merrick Kossack and Design Director Cory Costantino delivered a webinar on applying human factors engineering to software as a medical device. This debrief highlights some key topics presented.
First Quarter of 2024: Global Medical Device Regulatory Harmonization is the Theme
Global regulatory harmonization for medical devices appears to be the theme to start the year. Read Emergo by UL’s 2024 medical device regulatory insights.