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 | Twice weekly |
|---|---|---|---|---|---|
| Issues | 110 | Founded | 3 years ago | Last Issue | 2 months ago |
| Active | |||||
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hatemrabeh.substack.comLatest Issues
PMCF Mastery Episode 10: PMCF Lifecycle - Updates, Changes, and NB Interactions
Hey dear,
Welcome to the final episode of PMCF Mastery. Your PMCF plan is not a static document. It evolves as your device changes, evidence accumulates, and regulatory expectations shift.
Today we cover lifecycle management: when to upda...
PMCF Mastery Episode 9: Common PMCF Mistakes and How to Avoid Them
Hey dear,
Welcome back. Today we learn from others’ mistakes. I have reviewed hundreds of PMCF plans and reports. Notified Bodies have seen thousands. The same problems appear again and again.
Here are the top PMCF failures and how to avo...
PMCF Mastery Episode 8: Writing the PMCF Evaluation Report
Hey dear,
Welcome back. You have collected data through registries, surveys, and studies. Now you analyze it and write the PMCF Evaluation Report.
MDCG 2020-8 provides the template. But templates do not write themselves. Today we learn ho...
PMCF Mastery Episode 7: PMCF Methods - Post-Market Clinical Studies
Hey dear,
Welcome back. Sometimes registries and surveys are not enough. Some PMCF objectives require formal clinical studies.
PMCF studies differ from pre-market investigations. They study devices already on the market, in real-world con...
PMCF Mastery Episode 6: PMCF Methods - Surveys That Actually Work
Hey dear,
Welcome back. Surveys are the most used and most abused PMCF method. Easy to deploy. Hard to do well.
MDCG 2020-6 ranks high-quality user surveys at evidence level 4. General usability surveys rank at level 8. The difference is...
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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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