Regulatory News
Regulatory news and other exciting things happening in the regulatory world. Generally speaking, most updates here are about how your life is about to get more complicated and you’ll be writing even more documentation. But there are some much-appreciated exceptions!
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OpenRegulatory Newsletter #1: Conference
Dr. Oliver Eidel
updated 9 months ago
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MDR Classification Chaos and User Manuals
Dr. Oliver Eidel
updated 9 months ago
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ISO 13485 Amendment, Templates, User Manuals
Dr. Oliver Eidel
updated 9 months ago
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The IVDR Might Require 264 Notified Bodies
Dr. Oliver Eidel
updated 9 months ago
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Maybe Harmonized Standards Are Becoming Freely Available Soon
Dr. Oliver Eidel
updated 9 months ago
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July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
Dr. Oliver Eidel
updated 9 months ago
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Brace for Impact: The New MDR Transition Periods
Sven Piechottka
updated 9 months ago
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No, Telemedicine Software Is Not Class IIa Under The MDR
Dr. Oliver Eidel
updated 9 months ago