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....
What Is ISO/IEC 42001 and Why Does It Matter for AI Compliance?
Artificial intelligence (AI) is transforming industries, including healthcare and medical devices. As AI technologies advance, ensuring their responsible development, deployment, and management is crucial—especially for safety-critical...
Ethical AI Research and the Future of FDA Medical Device Compliance
The Ethical Imperative in AI-Driven Medical Devices Artificial Intelligence (AI) and Machine Learning (ML) technologies are rapidly transforming healthcare through innovations like Software as a Medical...