QRM

QMSR and The Quality Management System for Medical Devices

As the US transitions from the Quality System Regulation, or QSR, to the new QMSR or Quality Management System Regulation, they are aligning with ISO 13485. In this course, follow the fictional story of Elias who has an implantable cardioverter defibrillator. Learn about the quality management system regulation and documentation requirements that keep products safe for patients.

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CEU Credits: 0.1
Course Code: ELM-815
Duration: 10 mins
Skill Level: Intermediate
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 06/02/2026

Curriculum for this course

Meet Elias
Defining Processes
The ICD Battery Assembly Process
Risk Management
The ICD Lead Wire
QMSR Documentation
The Medical Device File
The ICD MDF
Control of Documents
ICD Document Controls
Control of Record
Summary
Test Your Knowledge
v1.0 | Course released on 07/28/2026.

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