ISO-13485-blog

All posts by: Sundeep Agarwal

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Suggested reading
How to classify medical devices according to the EU MDR
Advisera Kristina Zvonar Brkic Kristina Zvonar Brkic
April 22, 2021
With the new Medical Device Regulation, it is important for medical device manufacturers...
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List of mandatory documents required by ISO 13485:2016
Advisera Strahinja Stojanovic Strahinja Stojanovic
January 18, 2017
The new ISO 13485 is based on ISO 9001:2008, which means that the...
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What are the EU MDR technical documentation structure and requirements?
Advisera Kristina Zvonar Brkic Kristina Zvonar Brkic
April 6, 2021
The main purpose of technical documentation in the EU Medical Device Regulation (MDR)...
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