Monica Burt has spent 25 years in medical device quality. She led quality at Smith & Nephew, Medtronic and Wright Medical.
She then founded MB&A, a quality and regulatory firm for medical device companies and their investors. She took part in the Medical Device Single Audit Program (MDSAP) pilot and has stayed engaged with the program since.
She is a thought leader on applying artificial intelligence to medical device compliance and to speed to market, and writes about it in her newsletter, The Quality Signal. In 2025 she founded Qualera.
She is based in Memphis, Tennessee.