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 | 62 | Founded | 8 months ago | Last Issue | 7 days ago |
| Active | |||||
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leanraqa.substack.comLatest Issues
A Faster FDA Pathway Is Not a Shortcut Around Regulatory Strategy
“Faster pathway” has a way of making people dangerously optimistic.
Great. So this should be easier.
Not quite.
FDA’s 510(k) Third Party Review Program gives certain low- to moderate-risk devices another review route. For the right produ...
Your Supplier’s Quality Problem Can Become Your Remediation Problem
FDA’s recall pages have been looking a little repetitive lately.
Different products. Different companies. Same uncomfortable pattern.
A component has a problem, and the consequences start moving downstream.
We’ve been watching this in re...
Your Biocompatibility Strategy Should Start Before the Lab
Biocompatibility conversations have a funny way of starting with the lab.
What tests do we need?
Fair question.
I just wouldn’t make it the first one.
FDA is holding a Biocompatibility Risk Assessment Town Hall on September 9 to discuss...
Regulatory Strategy Is Starting to Follow the Patient Home
If the patient’s home is anywhere on your commercial roadmap, it probably belongs in your development conversations sooner than you think.
FDA gave device manufacturers another reason to pay attention when it recently announced the first p...
Your Medical Device Claims Strategy May Be More Important Than Your Launch Plan
If I were sitting with a client three months before launch, I would ask to see the claims deck before I asked for the submission timeline.
Because somewhere between FDA clearance and the first sales call, devices have a funny habit of beco...
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| Subscribers | Engagement | 65 | Monthly Web Visits | ||
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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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