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….
Harmonizing Device CGMP Requirements with International 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. […]
