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 | 32 | Founded | 4 months ago | Last Issue | 7 days ago |
| Active | |||||
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leanraqa.substack.comLatest Issues
Your Risk Management File Is Now a Commercial Asset
What CEOs Should Really Take From This:
- “State of the art” is an interpretive and strategic concept, not simply a technology benchmark.
Regulators increasingly expect manufacturers to justify devices against accepted medical practic...
Inside FDA’s Strange New Operating Environment
Over the last year, I’ve had more conversations that start with some version of: “What is FDA actually doing right now?”
The answer is complicated.
The agency is still reviewing submissions. Still clearing devices. Still conducting inspec...
QSIT is Over. Now What?
For years, most medical device companies prepared for FDA inspections using a familiar framework: QSIT.
Teams focused on subsystems. Mock audits followed predictable paths. Inspection readiness often centered on documentation and procedura...
Small Company. Same Standard.
“We’re small, so regulators will go easier on us.”
There is a particular kind of optimism that exists inside early-stage medical device companies.
You can usually spot it around Series A. Sometimes earlier.
The team is sharp. The scien...
FDA Clearance Doesn’t Mean You Have a Business
There’s a moment I see all the time in medtech: a company reaches FDA clearance—and assumes the hard part is over.
It’s not.
In many cases, that’s where the real challenges begin.
FDA gives you permission to market your device. It does n...
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| Subscribers | Engagement | 64 | Monthly Web Visits | ||
|---|---|---|---|---|---|
| Accepts Sponsors | Estimated Cost per Ad | ||||
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Authors
The writers behind this newsletter.
I help innovators bring safe, effective products to market—without losing their minds to regulatory chaos.
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