Quality

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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A review of the changes in ISO 13485

On February 25, 2016, the International Organization for Standardization (ISO) published its revisions to ISO 13485 replacing the previous version from 2003. This is the global standard for medical device quality management systems (QMS). Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition …

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