About this episode

Michaela Kivett discusses the complexities of implementing an electronic Quality Management System in MedTech.

In this episode, host Etienne Nichols sits down with Michaela Kivett, a seasoned medical device consultant at Greenlight Guru, to break down the complexities of implementing an electronic Quality Management System (eQMS). Drawing from her background in orthopedic implant contract manufacturing and pharmaceutical process engineering, Michaela shares firsthand accounts of the critical inefficiencies that plague traditional paper and generic electronic repositories like SharePoint or Google Drive. The conversation centers around the strategic planning required to transition between quality management states. Michaela introduces a powerful moving house analogy, illustrating that simply dragging and dropping messy, legacy records into a new digital environment will not solve underlying organizational issues. Instead, a successful migration requires an intentional internal self-evaluation, a culture of quality, and a structured, room-by-room approach to data and process transfer. Additionally, the episode highlights how forward-thinking MedTech companies are leveraging advanced tools, including artificial intelligence, to streamline their eQMS implementation. By using AI to scan…

People in this episode

Host: Etienne Nichols

Guest: Michaela Kivett

Topics covered

• eQMS
• MedTech
• quality management
• artificial intelligence
• data transfer
• organizational culture

Keywords

• eQMS
• quality management
• MedTech
• artificial intelligence
• ISO 13485
• data migration
• organizational efficiency

Mentioned in this episode

Organizations: Greenlight Guru, ISO 13485

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