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janvier 31, 2023

Free Webinar PDF Download | Medical Device Sterilization – Addressing EPA’s Clean Air Act

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janvier 31, 2023

On-Demand Webinar | Medical Device Sterilization – Addressing EPA’s Clean Air Act

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janvier 31, 2023

Proposed Extension of Transition Period of the MDR: Don’t Take Your Foot off the Gas!

Before you go on reading, keep in mind nothing is set in stone yet. The proposal still needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.
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janvier 18, 2023

Basic Safety Standards 60601 vs. 61010-1

Do you know the difference between safety standards 60601-1 vs 61010-1 in medical devices and in vitro diagnostics? Find out ways to differentiate these safety standards and learn more in his newly released blog, Basic Safety Standards 60601 vs. 61010-1, It's Almost Binary. 
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janvier 12, 2023

New MDCG Guidance on Periodic Safety Update Report (PSUR) - What's in it for IVD Manufacturers?

The PSUR is one of the new European requirements for higher-risk medical devices and in-vitro diagnostic medical devices (IVDs). Read the blog with requirements for IVDs and how the MDCG guidance provides valuable insight into the expectations on scope, structure, and content of PSURs for IVD devices. 
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