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 | 52 | Founded | 7 months ago | Last Issue | 6 days ago |
| Active | |||||
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leanraqa.substack.comLatest Issues
ISO 13485 Certification Is Not an FDA Readiness Strategy
There is a sentence that continues to surface in executive meetings with remarkable confidence:
“We’re ISO 13485 certified, so we’re ready for FDA.”
That conclusion has always been a little ambitious. Under QMSR, it may become even more t...
The Most Important MDUFA VI Change May Not Be the Fees
The proposed MDUFA VI agreement includes several changes likely to attract immediate attention: lower submission fees, a fee for certain pre-submissions, faster follow-up feedback, revised de novo procedures, and additional coordination bet...
The Most Expensive Regulatory Decisions Don't Feel Regulatory
On the surface, it's an unremarkable leadership meeting. A handful of perfectly reasonable decisions are made, a few action items are assigned, and everyone leaves believing the project is moving exactly as planned. Nobody realizes they’re...
Why Your FDA Pre-Submission Shapes Every Review That Follows
One of the more interesting shifts in FDA interactions isn’t happening during the 510(k) review itself. It’s happening long before the submission ever arrives.
For years, many organizations treated the pre-submission program as an informal...
Closing the Observation Doesn't Always Solve the Problem
The belief that closing an FDA observation means the underlying problem has been solved has survived for decades.
It’s also one of the reasons remediation projects become far more expensive than they need to be.
The observation isn’t the...
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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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