Risk Management Under QMSR: Practical Implementation Guide
Risk management is the philosophical centerpiece of ISO 13485—and by extension, QMSR.
More issues
DMR to MDF Transition: Complete Documentation Migration Guide
This guide clarifies exactly what's changing, what's staying the same, and what actions (if any) you need to take.
In this article:
The real differences between DMR and MDF
DHF to Design File transition explained
DHR to Batch Record requirements
Three approaches to documentation migration
QMSR Pre-Mortem: Why Envoy Medical’s Warning Letter is a Textbook Case of "Siloed Risk" Failure
QMSR Pre-Mortem: Envoy Medical just gave the industry a preview of what FDA will target in 2026.
One Warning Letter.
Two severity ratings for the same infection risk.
Seven months of uninvestigated complaints.
Not a documentation miss — a system logic failure.
QMSR for US-Only Companies: Complete Transition Playbook
If your medical device company sells exclusively in the US market, you've probably been operating under 21 CFR Part 820 without much thought about ISO 13485. You weren't selling in Europe or other markets that required ISO certification, so why bother?
QMSR changes that calculation entirely.
How to Conduct a QMSR Gap Analysis (Free Template Included)
Reading time: 14 minutes | Last updated: December 2024
A gap analysis is the first real step in QMSR transition—and possibly the most important. Without understanding exactly where your current QMS falls short of QMSR requirements, you're guessing at priorities, likely wasting effort on low-impact changes, and potentially
QMSR Timeline: Every Critical Date Before February 2026
This article provides a comprehensive timeline of QMSR-related dates, recommended milestones for your transition, and a realistic assessment of what's still achievable given the time remaining
FDA Warning Letters Up 96% — Here's What That Means for You
QMS.Coach Newsletter
Week of December 3, 2025
60 Days Until QMSR. Are You Ready?
The countdown is on.
On February 2, 2026, the FDA's new Quality Management System Regulation (QMSR) takes effect—and there are no extensions coming. If you're still running your QMS under
QMSR vs QSR: 15 Critical Differences You Need to Know
QMSR vs QSR: 15
Critical Differences You
Need to Know
The FDA's Quality Management System Regulation
(QMSR) replaces the Quality System Regulation (QSR) on February 2, 2026.
How to Conduct a QMSR Gap Analysis (Free Template Included)
đź“– 14 min read
đź“… Updated December 2024
🏷️ QMSR Compliance
How to Conduct a QMSR Gap Analysis (Free Template Included)
A gap analysis is the first real step in QMSR transition—and possibly the most important. This guide walks you through a systematic approach with a free downloadable Excel template you can
COMPLETE QMSR Compliance Guide
QMS.Coach provides QMSR transition consulting for medical device manufacturers—from startups building their first QMS to Fortune 500 companies navigating complex FDA inspections.