Overview

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Seven quality management principles
An effective quality management system is a suitable tool for companies to meet the daily ...
May 31, 2022
# Quality management requirements
Revision of ISO 27002 - These are the changes
#27002: A refreshing revision of the standard with a streamlined structure, new content and ...
May 08, 2022
# Information Security Standards
Great Britain's exit from the EU and the consequences for the medical device market
How long can I continue to supply my medical devices to the UK? That is one of many questions. We ...
May 05, 2022
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# Health care certifications
What to do with reusable surgical instruments of class "Ir" under the MDR?
Do you manufacture reusable surgical instruments of class lr and would like to find out about the ...
May 05, 2022
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When is software a medical device under the MDR?
The requirements of the MDR pose new challenges for manufacturers of software that is to be ...
May 05, 2022
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# Health care certifications
What to do with so-called "material" medical devices under the MDR?
Combination products containing medicinal products or active substances can be covered under both ...
May 05, 2022
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# Health care certifications

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