the leanRAQA Substack
leanRAQAWhere quality and regulatory judgment meet commercial reality.
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 21 | Subscribers | Read | leanraqa.substack.com |
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Latest Issues
Recent posts by this newsletter. Browse the email archive.
Medical Device 101: FDA Medical Device Classification
Sift through the FDA’s risk-based classification system for medical devices — what it means, how it’s structured, and what types of controls apply to each class.
Clinical Burden Doesn’t Kill Deals. Uncertainty Does.
There’s a common concern in medtech fundraising: does the cost and complexity of clinical and regulatory work scare investors away? Sophisticated investors aren’t deterred by a de novo timeline or a large clinical budget—they’re deterred by...
WHOOP, “Inherent Use,” and the Regulatory Inflection Point
WHOOP called it general wellness. FDA called it medical.
791 FDA 483s. Only 54 Warning Letters. Here’s What That Really Means.
FDA issued 791 Form 483s last year — and only 54 warning letters.
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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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