ISO-13485-blog

Tag: “Measurement”

How to comply with section 8.2 Monitoring and measurement in ISO 13485:2018
Advisera Verlene Law Verlene Law
September 20, 2018
Blog
Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management...
Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have met the expectations in...
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Integrated EU MDR & ISO 13485 Toolkit
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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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What are the EU MDR technical documentation structure and requirements?
Advisera Kristina Zvonar Brkic Kristina Zvonar Brkic
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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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