Medical Device Regulatory Briefing
leanRAQADeep-dive insights on FDA regulation, claims, and commercialization strategy in medtech.
| Platform |  | Pricing | Only free issues | Publishes | Twice weekly |
|---|---|---|---|---|---|
| Issues | 69 | Founded | 9 months ago | Last Issue | 9 days ago |
| Active | |||||
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Real-World Evidence Is Only Useful If You Planned for It
FDA is putting more attention on real-world evidence in medical devices, including this week’s Grand Rounds focused on CDRH’s RWE program and recent device examples.
Nobody in this industry needs convincing that real-world data can be valu...
The Device Failure Isn’t Always the Biggest Risk
Two recent FDA Early Alerts caught my attention for very different reasons.
One involved a transcatheter mitral valve delivery system where a balloon burst could make normal retrieval difficult and potentially require surgery in a patient...
FDA’s 2027 Priorities Are Pointing to One Bigger Shift
FDA published its proposed FY 2027 CDRH guidance priorities on October 1, and the interesting part is not the list itself.
It is what happens when you put the priorities next to each other.
AI-enabled device software lifecycle management....
Stop Asking for the Minimum
When I advise the CEO of an early-stage medical device company, there is one question I absolutely challenge: “What is the minimum we need to do to get through FDA?”
I get why people ask it. Money is finite. Runway is real. Nobody gets a m...
QMSR Inspections: What Happens When FDA Starts Pulling Threads?
QMSR has been in effect since February, which means most companies have already updated procedures, retrained people, and checked the transition boxes.
Great.
Now I want to know whether the quality system actually holds together when some...
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| Subscribers | Engagement | 66 | Monthly Web Visits | ||
|---|---|---|---|---|---|
| Accepts Sponsors | Estimated Cost per Ad | ||||
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Authors
The writers behind this newsletter.
I help medical technology innovators bring safe, effective products to market—without losing their minds to regulatory chaos.
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