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Implementation ISO 13485 on making medical materials for medical laboratories

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Guest user Created:   Sep 01, 2021 Last commented:   Sep 01, 2021

Implementation ISO 13485 on making medical materials for medical laboratories

For the ISO 13485, I know it is applicable for the manufacturing of clinical chemistry reagents since it is used for the diagnostics tests, is it correct?

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Kristina Zvonar Brkić Sep 01, 2021

Yes, clinical chemistry reagents are considered to be in vitro diagnostic medical devices, therefore ISO 13485:2016 is apllicable as quality management standard.  

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Sep 01, 2021

Sep 01, 2021