The European AI Act: Requirements for High-Risk AI Systems
Emergo by UL has been reporting on the landmark legislation that is the Artificial Intelligence Act (AIA). As the AIA was given the green light by EU institutions and the finish line is in sight, it seems fitting to conclude our regulatory series with a brief recap, as well as a focus on the high-risk AI systems on which the regulation is mainly concerned.
Legislation Published to Delay Compliance for Legacy IVDs and EUDAMED Rollout
Additional legislation officially amending the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/745, IVDR) was published as Regulation 2024/1860 on June 13.
Noteworthy Strategies: Optimizing Data Collection During Complex System Usability Tests
Learn strategies for high-quality data capture in complex systems usability tests. Discover tips on structuring data collection tools, setting up test environments and synthesizing data.
Second Quarter 2024: Global Medical Device Regulatory Harmonization Continues
In this update, we take a whirlwind tour of countries exemplifying regulatory reliance, IVD updates and global harmonization modeling.
M&A Regulatory Due Diligence Services for Medical Devices
Our expertise supports regulatory compliance that is seamlessly integrated into your M&A strategy, facilitating smooth transitions and helping to preserve the value of your transactions.
IMDRF Updates Guidance on Global Regulatory Submissions
Global harmonization of medical device registration submissions is one way to advance the objectives of the International Medical Device Regulators Forum (IMDRF) and regulatory reliance. These documents are a must-read for any serious regulatory professional. For medical device manufacturers, here we elaborate on our regulatory update from April 2023.
US FDA, Health Canada and UK MHRA Update on Transparency Guiding Principles for Machine Learning-Enabled Medical Devices
The US Food and Drug Administration (FDA), Health Canada and UK MHRA (June 13) built on their 2021 guiding principles for good machine learning practice for medical device development by further identifying guiding principles for transparency for machine learning-enabled medical devices (MLMDs).
The European Artificial Intelligence Act: Penalties and Timelines
This is the third in our series of regulatory updates on the EU Artificial Intelligence Act (AIA). In this article, we examine relevant timelines and penalties for medical device manufacturers in the EU.
Some Assembly Required: Unique Considerations for Applying Human Factors to a Medical Products System
Emergo by UL human factors specialists discuss how to apply human factors engineering to medical products as a system.
Validate Smarter, Not Harder: Exploring the Scope of Critical Tasks in an HF Validation Test
Discover efficient approaches to streamline HF validation testing for medical devices. Learn about alternative methods, regulatory insights and best practices from Emergo by UL.