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Tag Archives: audit

The new QMSR and the FDA inspections
19 Jan

The new QMSR and the FDA inspections

FDA UPDATE The new QMSR and the FDA inspections – be aware!!!! IN a few short weeks, a major change in the FDA regulations pertaining to the manufacturing of medical devices since 1997 will go into effect. The FDA is changing the Quality System Regulations (QSR) to the Quality Management System Regulations (QMSR). What does

21 Mar

MDSAP AND A MDSAP AUDIT EXPERIENCE

by ALAN SCHWARTZ ABSTRACT The Medical Device Single Audit Program (MDSAP) is a new medical device auditing plan with potential for several advantages. This discussion addresses an actual MDSAP audit experience and demonstrates how the organization dealt with its complexities. The MDSAP program is described including country involvements. Audit personnel and experiences are discussed. Example

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