About
Quality people, building for quality people.
Qualera, Inc. was founded in 2025 in Memphis, Tennessee, by Monica Burt. It grew out of MB&A, the medical device quality and regulatory firm she started in 2019, and out of years of watching good teams get surprised by findings that were sitting in their own records.
Founder and CEO
Monica Burt
- 25+ years in medical device quality
- 300+ audits against FDA, ISO, MDSAP and other global regulations
- Took part in the MDSAP pilot and has stayed engaged since
Monica led quality at Medtronic, Smith & Nephew and Wright Medical before founding MB&A. She is Founder and CEO of both MB&A and Qualera, and writes about artificial intelligence in medical device compliance in The Quality Signal.
Qualera and MB&A
One builds the platform. The other puts its name on the audit.
MB&A is Qualera's founding operator. Its auditors run every client engagement today, and they decide every finding the platform raises.
That arrangement is deliberate. Regulated work needs a person who answers for the result, and the platform keeps getting better because the people using it every week have spent their careers in device quality.
Start here
Tell us about your device and your next audit or inspection.
We'll tell you what Qualera can do for your team right now, and where you'd fit in the platform pilot group.