Your FMEA Is a Snapshot. The FDA Wants a Movie.
The companies that are ready for their next inspection aren't the ones with the most sophisticated FMEA software. They're the ones where complaint data flows into the risk file
Topic
FDA
A collection of 13 issues
QMSR Implementation & Inspection Readiness: A Comprehensive Fact-Check and Operational Analysis of the February 2, 2026, Transition
The transition to QMSR is not merely a bureaucratic exercise in updating citations; it represents a fundamental philosophical pivot from a compliance-based model to a risk-centric, Total Product Life Cycle (TPLC) regulatory framework.4
FDA Compliance Program 7382.850: The definitive guide to medical device inspections under QMSR
Beginning February 2, 2026, FDA inspections of medical device manufacturers fundamentally changed. The new Compliance Program 7382.850 (CP 7382.850) replaces both the QSIT methodology and CP 7382.845
Building Your First QMSR-Compliant QMS from Scratch
If you're a medical device startup building your first quality management system, you have an advantage: you can build it right from the start. You're not transitioning from QSR to QMSR—you're starting fresh with QMSR requirements as your foundation.
QMSR Supplier Quality Requirements: Complete Management Guide
Supplier quality management under QMSR is more explicitly risk-based than under QSR. ISO 13485:2016 Clause 7.4 requires
QMSR Compliance: Common Mistakes and How to Avoid Them
With the February 2, 2026 deadline approaching, companies are rushing to implement QMSR requirements. Speed creates risk. We're already seeing patterns of mistakes that will likely result in FDA findings—or worse, will require expensive rework after the deadline.
What to Expect in Your First QMSR Inspection
FDA inspections after February 2, 2026 will look different. Inspectors will reference ISO 13485 clause numbers instead of QSR sections. They'll request records that were previously exempt—management review minutes, internal audit reports, supplier audit documentation.
ISO 13485 and QMSR: What Your Certification Actually Means Now
If you're ISO 13485:2016 certified, you might assume QMSR transition is automatic. After all, QMSR incorporates ISO 13485:2016 by reference. Same requirements, same regulation—right?
Not quite. Your certification demonstrates compliance with ISO 13485:2016, but QMSR adds FDA-specific requirements
QMSR Terminology Glossary: Old vs New Definitions
One of the most practical challenges in QMSR transition is vocabulary. After years of speaking QSR, you suddenly need to speak ISO 13485. Your procedures say "establish," the standard says "document." You've always had a DMR, now you need an MDF.
Risk Management Under QMSR: Practical Implementation Guide
Risk management is the philosophical centerpiece of ISO 13485—and by extension, QMSR.