From Reactive Compliance to Predictive Resilience: Governed AI for Knowledge Management and Supply Chain Integration in Class II Medical Device Operations – A Case Study
Digital Technologies, AI and Organizational Innovation: 47ISM 2026
Small and mid-sized Class II medical device manufacturers face a scale-up challenge when regulatory, quality, and supply chain information grows faster than the organization’s ability to manage it. This paper examines whether governed artificial intelligence can convert fragmented records into decision-ready knowledge without weakening compliance,…