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Tag Archives: audit

The new QMSR and the FDA inspections
19 Jan

What FDA Inspectors Are Actually Checking Under the New QMSR

FDA UPDATE What FDA Inspectors Are Actually Checking Under the New QMSR — mdi’s First-Hand Findings The FDA’s QMSR replaced the old QSR on February 2, 2026 — and if your quality system documents still reference 21 CFR Part 820 sections instead of ISO 13485 clauses, your next FDA inspection will expose that gap immediately.

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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