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FDA is aligning its QSR (21 CFR 820) with ISO 13485:2016

By 2020, the Food and Drug Administration (FDA) is planning to change its quality system requirements for medical device manufacturers stipulated in 21 CFR 820 by ISO 13485 :2016. This decision was taken as more and more regulators are looking toward adopting globally harmonized requirements that utilize regulations as well as standards, such as ISO …

FDA is aligning its QSR (21 CFR 820) with ISO 13485:2016 Read More

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