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Faits marquants

septembre 27, 2022

Essential Performance & Single Faults – Gray Issues for Grey Matter! (Part 2 of 2)

Understanding the single fault expectation is important for effective and compliant risk management.

IEC 60601-1 Medical Devices Highlights

Résultats

janvier 31, 2023

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

Medical Device Regulations

janvier 31, 2023

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

Medical Device Regulations On-Demand Webinar Highlights

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.

MDR 2017/745 Highlights

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.

Medical Device Regulations 60601 61010-1 Highlights

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.

In-Vitro Diagnostics IVDR MDCG PSUR PMPF Highlights

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