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MoFo Life Sciences

Quality Management System Regulation (QMSR) – Harmonizing The Quality System Regulation (QSR) With ISO 13485:2016

MoFo Life Sciences on

The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820)...more

Thomas Fox - Compliance Evangelist

For the Benefit of Mr. Kite – Fiction in the World of Quality Assurance

Thomas Fox - Compliance Evangelist on

The basics were laid out by Peter Wells and Emiko Terazono in a Financial Times (FT) article entitled “Kobe Steel scandal hits Boeing, Toyota and Nissan”. The Japanese company admitted it had falsified “inspection data on an...more

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