Is Your AI-Generated Document Compliant? A QC Checklist
Artificial Intelligence (AI) is quickly becoming a valuable tool for medical device developers, capable of drafting everything from technical files to marketing materials in record time....
Understanding IEC 42005
The rise of Artificial Intelligence (AI) and Machine Learning (ML) is rapidly changing the medical device landscape. These powerful technologies offer incredible potential, but they also...
A Simple Guide to the EU AI Act & ISO/IEC 42001
The world of medical devices is rapidly evolving with the integration of Artificial Intelligence. While this brings exciting new possibilities, it also introduces new regulatory challenges....
Navigating FDA’s New Draft Guidance on AI-Enabled Device Software Functions
The FDA's draft guidance, "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations", represents a significant step toward addressing the complexities of AI in...