Beyond Regulation with Ceren: Insights, Career & MedTech
Dr. Ceren Karacay-SteinwenderThis newsletter will give you exactly what you need: Regulatory Insights, Career Tips and News in MedTech
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 13 | Founded | a year ago | Last Issue | 7 days ago |
| Active | |||||
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beyondtheregulation.substack.comLatest Issues
Issue 13: Free Resources to polish your technical knowledge
Did you also finish your school year and enter the summer holidays by mid-June? I did!
Where I grew up, in Türkiye, the summers start early and, with the heat, it is impossible to concentrate anymore. So, we used to finish school and the u...
Issue 12: Change Control Approved: Switching to Summer
Watch the podcast where I answered, “How did I end up in Regulatory Affairs and what the h!ll we do everyday”
Links:
Spotify: https://lnkd.in/eu3U_54t
Apple podcasts: https://lnkd.in/e3ucghsp
Youtube: https://lnkd.in/e7vYP...
Issue 11: How to Choose? Small company vs Corporate Setting
Regulatory affairs moves fast. Guidelines get updated, deadlines shift, and new frameworks come into force before most courses have a chance to cover them.
That is exactly why this newsletter covers important regulatory news. The goal is t...
Issue 10: Regulatory Affairs: The Art of Stakeholder Debate
The recent IVDR and MDR proposals have confirmed what we already know: regulatory affairs is dynamic and multifaceted. Manufacturers, the EU Commission, Notified Bodies, and MedTech Europe all claim to prioritize patient safety, yet their p...
Issue 9: Why I Sit Through the Whole Audit?
Last week I sat through a two-and-a-half-day Notified Body surveillance audit. All sessions, start to finish.
My role was to cover Regulatory Affairs topics: Regulatory Intelligence, Post-Market Surveillance, and Vigilance. But I stayed fo...
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The writers behind this newsletter.
Hi, I’m Ceren. I climbed the ladder in academia only to jump off—straight into the world of regulatory affairs. In this newsletter, I share what I’m learning and discovering along the way. Join me!
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