Risk Management Under QMSR: Practical Implementation Guide
Risk management is the philosophical centerpiece of ISO 13485—and by extension, QMSR.
Topic
QMSR
A collection of 13 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
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