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A collection of 9 issues

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

Risk Management Under QMSR: Practical Implementation Guide

Risk management is the philosophical centerpiece of ISO 13485—and by extension, QMSR.

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

How to Conduct a QMSR Gap Analysis (Free Template Included)

📖 14 min read 📅 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

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