Monica Burt
Monica Burt has spent 25 years in medical device quality. She led quality at Smith & Nephew, Medtronic and Wright Medical, then founded MB&A, a quality, regulatory and recruiting firm with more than 200 FDA and ISO audits behind it. Device makers and their investors bring MB&A in for remediations, due diligence and inspection readiness. In 2025, she founded Qualera, an AI audit platform built on a simple idea: an audit shouldn't be a guessing game about which records to pull. She also publishes The Quality Signal, a newsletter on medtech quality, and is based in Memphis.
Thursday October 8, 2026
AI and Automation on the Production Floor
Most organizations recognize artificial intelligence (AI) can help improve processes and procedures, but still remain uncertain on how to implement it effectively. As a result, there are still reservations about incorporating it into a company’s manufacturing protocols. The panel for this session will attempt to alleviate common fears with using AI, eliminate misconceptions, and provide early steps for adoption. Targeting low-hanging fruit areas, the panel will offer best practices and important considerations that must be addressed before moving further into adoption.
Moderated by Monica Burt