#462: Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders
Michaela Kivett, a medical device consultant at Greenlight Guru, explains the strategic implementation of an electronic Quality Management System (eQMS) using a 'moving house' analogy to warn against simply migrating messy legacy data. She details the operational friction of paper-based or generic repository systems like SharePoint, highlighting issues with version control, physical signatures, and tracking personnel across large facilities. The conversation emphasizes leveraging AI to scan documents for ISO 13485 compliance gaps and automating workflow updates to mitigate the efficiency dip during transition. Kivett argues that successful adoption requires a culture of quality and a structured, room-by-room self-evaluation of procedures rather than just installing new software.