United States

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 …

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Unique Device Identification (UDI) Systems Expansion in Europe

The implementation of Unique Device Identification (UDI) systems in markets beyond the US is increasing, as the European Commission is planning to publish a guidance document on UDI under the MDR and IVDR in March 2018. It became clear that most markets will have a UDI system within five years . Although it will be …

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