Clinical Evaluation Navigator
Hatem RabehStay ahead in the medical device field with concise, insightful updates on clinical evaluation. Our newsletter brings you the latest updates on regulatory standards, offering practical advice and expert analysis tailored to your professional needs.
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 116 | Founded | 3 years ago | Last Issue | 6 days ago |
| Active | |||||
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hatemrabeh.substack.comLatest Issues
Could a Stranger Rerun Your Literature Search?
One missing search string can cast doubt over your entire clinical evaluation.
The deficiency email lands. A PDF is attached. You open it and scan the comments, and the afternoon rearranges itself around what you find. The reviewer is ques...
Equivalence Dies on the Pillar Everyone Ignores
Hey friend,
One overlooked material difference can bring an entire equivalence claim down.
The hard part is that many teams discover it only after they have invested months of work.
Yesterday was special. A notified body reviewer sat wit...
Three Routes to Clinical Evidence, One Expensive Wrong Turn
Hello friend,
One early decision can quietly determine whether your clinical evaluation moves forward or stalls at the review gate.
It is the decision about which route will generate your clinical evidence.
Of all the decisions in a clin...
The Numbers You Must Set Before You See Your Data
One threshold in your CEP can make a reviewer trust the whole evaluation.
Or question every conclusion that follows.
I once sat in the room when it happened. A reviewer reaches the acceptance criteria, pauses, and asks a simple question:...
Benefit-Risk: Why Your Analysis Looks Good but Fails Review
Hello dear,
One favourable-balance sentence can still leave your CE mark waiting at the gate.
I have watched this happen too many times, and it always stings.
A team has worked hard. Really hard. Their benefit-risk section runs for pages...
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Authors
The writers behind this newsletter.
Join Dr. Hatem Rabeh for key insights into medical device clinical evaluation. Elevate your expertise with guidance from a seasoned MD, engineer, and data scientist.
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