Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...

FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...

With increasing interest in and demand for patient-specific medical devices, such as anatomically matched 3D printed implants ...

Forward-thinking manufacturers build native compliance protocols as a workflow, not as an afterthought—a pitfall that many ...

CONNEQT Health has taken a major step forward in its transformation from a medical device company to a scalable cloud-based platform business by lodging an application with the US Food and Drug ...

Pharmaceutical, medical device, and biotechnology industries live and breathe regulation. Every computerized system that impacts product quality, patient data, or manufacturing processes must go ...

While public conversations may often focus on chatbots and workplace automation, To sees specialized AI systems trained on ...

The technology has some promising applications, but is not ready for whole body cancer screening and will not replace other ...

CorePlus, Puerto Rico's fully digital precision pathology and clinical laboratory, announced today the integration of the ArteraAI Prostate Test into its diagnostic workflows, becoming the first ...

As artificial intelligence (AI) tools continue to reshape healthcare delivery and operations, legal and compliance teams should proactively navigate ...