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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
Sep 01, 2021