Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries.
Journal:
Therapeutic innovation & regulatory science
Published Date:
May 18, 2023
Abstract
PURPOSE: The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in vitro diagnostics (IVD), poses new regulatory problems: a lack of a common terminology and understanding leads to confusion, delays and product failures. Validation as a key step in product development, common to each of these sectors including computerized systems and AI/ML development, offers an opportune point of comparison for aligning people and processes for cross-sectoral product development.