Updates in the field of artificial intelligence and software-enabled medical device
Be aware of ISO 42001-the Standard that provides the framework for implementing a comprehensive AI management system that is secure, ethical, and aligned with the latest global standards. FDA (Jan-2025) releases Draft Guidance (not yet for implementation): Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations Artificial Intelligence-Enabled Device Software...
Navigating the Latest Regulations on Laboratory Developed Tests (LDTs)
Laboratory Developed Tests (LDTs) play a crucial role in modern healthcare, enabling laboratories to develop tests tailored to specific medical needs. Recently, the regulatory landscape for LDTs in the United States has undergone significant changes. Here’s a breakdown of the latest regulations and what they mean for laboratories and patient...