Why subscribe?
I’m Monica Burt. I’ve spent 25+ years inside MedTech quality systems and conducted more than 200 FDA and ISO audits as a consultant, an internal lead, and an outside expert. I founded MB&A to do the work I kept seeing companies fail at: building quality systems that actually hold under inspection. I founded Qualera to bring AI to the work that should never have been done by hand in the first place. The Quality Signal is where I write in my own voice about what I see across the industry.
The Quality Signal is strategic intelligence for MedTech quality and regulatory leaders, and for the investors and operators who fund or acquire them. It covers FDA enforcement, the QMSR transition, ISO 13485 in practice, AI in regulated manufacturing, and the operational reality that lives inside actual quality systems. No marketing copy. No vendor pitches. No recycled FDA press releases. Just the operator’s view of what’s actually working, what’s actually failing, and what to do about it.
It’s written for VPs of Quality, Chief Compliance Officers, Heads of Regulatory, and the boards and investors backing them. If you’re a quality leader who wants to know what’s coming before it lands as a 483 observation, this is for you. If you’re an investor who needs to read a target’s quality system the way the FDA will, this is for you. If you’re somewhere upstream of either, the patterns I cover here will eventually become your problem.
The publication runs in three sections. Field Notes, weekly, free: a tight intelligence brief on what shifted this week. The Signal, twice monthly, mixed free and paid: longer strategic analysis that connects enforcement to operating decisions. The Front Room, monthly, paid only: the front room is where the regulator sits during an audit. The back room is where the flurry of activity happens that feeds the front room. This section is named for where the action lands, because that’s where careers and approvals get decided. Anonymous case studies from inside actual audits, predictive enforcement coverage, and the synthesis that can’t run public. Subscribe to start with the free streams. Upgrade when the paid section becomes worth more to you than the cost of one billable hour.
Monica Burt Founder, MB&A and Qualera
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