For medical technology companies, regulatory excellence depends on more than meeting compliance requirements. Fragmented systems, manual documentation reviews, and complex quality processes can slow audit preparation, defect resolution, and CAPA workflows while increasing pressure on already constrained teams.
This case study reveals how Cyient helped a European medical technology OEM embed AI into governed regulatory and quality workflows through an AI Center of Excellence and intelligent assistants. The AI-augmented model automated documentation checks, accelerated defect analysis, and streamlined CAPA and governance workflows, reducing audit preparation time by 63%, documentation review hours by 80%, and CAPA cycle time by 50%, while improving documentation accuracy from 78% to 95%.