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Field Notes: The Clock Runs Both Ways
Three regulatory and industry shifts that signal where medtech enforcement and operations are heading next.
Jun 3
•
Monica Burt
2
Field Notes: First QMSR Cycle, First Cracks
What the first months of QMSR enforcement are already revealing about FDA calibration, inspection behavior, and regulatory drift.
May 21
•
Monica Burt
1
The Signal: FDA Did Not Go Soft. FDA Reloaded.
One hundred days into QMSR, the headline number looks like relief.
May 20
•
Monica Burt
1
Field Notes: The Stage and the Press Release
FDA’s AI strategy is evolving faster than its guidance — and the gap is becoming impossible to ignore.
May 12
•
Monica Burt
1
FDA's AI Will See You Now
FDA is no longer just regulating AI — it is actively using AI to inspect, prioritize, and evaluate the medical device industry. This edition of The…
May 8
•
Monica Burt
2
Field Notes: Sharper, Not Softer
Three months into QMSR, FDA enforcement may appear quieter on the surface — but the underlying signals tell a different story. This edition of Field…
May 8
•
Monica Burt
1
The Quality Signal
Strategic intelligence for MedTech quality leaders and the investors backing them. FDA enforcement, QMSR shifts, AI in regulated manufacturing. Written by Monica Burt. 25+ years and 200+ audits in.
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