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Harmonizing Device CGMP Requirements with International Standards

by | Mar 1, 2022

In 2018, the US agreed to harmonize its domestic good manufacturing practices with agreed-to international standards in accordance with the Medical Device Single Audit Program (MDSAP). On Feb. 23, the Food and Drug Administration (FDA) made its contribution to that effort by publishing a proposed harmonization rule for medical device quality management systems (QMS) standards. […]

In 2018, the US agreed to harmonize its domestic good manufacturing practices with agreed-to international standards in accordance with the Medical Device Single Audit Program (MDSAP). On Feb. 23, the Food and Drug Administration (FDA) made its contribution to that effort by publishing a proposed harmonization rule for medical device quality management systems (QMS) standards. […]

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