FDA Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices
Guidance for manufacturers developing ML-DSF-enabled devices to rapidly iterate, develop and improve under the highly adaptive nature of AI and ML.
Determining When It’s Possible to Forgo HF Validation Testing
HF validation testing may not be necessary for medical and drug delivery devices. Learn from Emergo by UL's insights on navigating FDA regulations and developing sufficient justifications.
Similar but different: the importance of combination product differentiation
Emergo by UL's Human Factors Specialists share key considerations for combination product differentiation.
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.
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.
Emergo by UL's Key Takeaways from the Finalized Version of China's NMPA HFE Guidance
On March 19th, 2024, China’s National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) released a finalized version of its guidance about the application of human factors engineering (HFE) / usability engineering (UE) to medical device development. In this succinct article, we address the changes and updates from the prior draft guidelines for public comment, released in October 2023.
Using Desk-based Readability Assessments to Evaluate the Labeling of Medical Devices
Desk-based readability assessments are a time and resource-effective method of evaluating the readability of your labeling, including your instructions for use (IFU), quick reference guide (QRG) or other user-facing documents (e.g. patient information leaflets). In this article, Emergo by UL discusses the applications of readability assessments and presents an overview of three methods.
New Medical Device Usability Engineering Standard from MHLW
The new JIS T62366-1:2022 standard comes with updated requirements on usability engineering for medical devices.
Developing HFE Strategies to Meet Global Regulations
Understand key global regulators’ HFE expectations, and what HFE activities to perform and deliverables to prepare, to meet those expectations.