Tag Archives: QMSR

Complaint Handling Under QMSR: Where the FDA Audit Trail Begins

Short answer: Since February 2, 2026, complaint handling under 21 CFR Part 820 is governed by ISO 13485:2016 Clause 8.2.2 together with FDA's supplemental record requirements in § 820.35. Medical Device Reporting under 21 CFR Part 803 did not change: manufacturers must report a death, serious injury, or reportable malfunction within 30 calendar days of

The Mid-Year FDA Compliance Check: 5 Things to Verify Before Q3

Short answer: Before Q3 begins, medical device companies should verify five key compliance areas: FDA establishment registration, QMSR implementation, inspection readiness, U.S. Agent designation (for foreign manufacturers), and the status of any open FDA 483 corrective actions. Addressing these items now can help avoid compliance issues and last-minute challenges during the October registration renewal period.

What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings

What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings The single biggest focus area in every QMSR inspection that MDI has participated in is not your quality manual, SOPs/work instruction, documentation structure or your terminology — it is your organizations ability to demonstrate risk-based thinking embedded throughout your entire quality

The new QMSR regulations – and Risk Analysis

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

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.