Quality by Intelligence: A Review of AI Applications in Healthcare Product Lifecycle Management

Abstract

The evolution of healthcare products development and their quality assurance is changing rapidly owing to the artificial intelligence (AI), as it allows quicker innovation, increased safety, and better regulatory compliance. The paper discusses the role of AI technologies in the whole product lifecycle, starting with early research and design and continuing with prototyping, manufacturing, and after-sale surveillance. The main advantages are automated defect detection, predictive analytics, optimization of processes, and intelligent decision support that, respectively, enhance the quality of products and patient safety. Other regulatory considerations, ethical issues, and restrictions discussed in the review include data quality and model transparency. Lastly, there are new adaptive AI, digital twins, and patient-centric trends, which represent the future path of AI-driven healthcare innovation.