: 516-482-9001

Tag Archives: QMSR

The new QMSR regulations
21 Apr

The new QMSR regulations – and Risk Analysis

April 21, 2026 - 2:02 pm
FDA Updates, Medical Device Industry
By

We recently participated in FDA inspections using the new QMSR (Quality Management Systems Regulations). These inspections were very interesting. One was conducted at a foreign client in China the other was in the USA. These inspections went directly to the QMSR and expected that the companies were following the new regulations. If you are already

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.

Archives