Course curriculum

    1. How to Use This Course

    2. Course Overview

    1. Introduction to QMSR

    2. Download QMSR Final Rule

    3. Download Free ISO Standards

    4. QUIZ: Overview

    1. Terms and Definitions

    2. Changes to Definitions

    3. Download Glossary of Terms and Definitions - Medical Device

    4. QUIZ: Terms and Definitions

    1. ISO 13485:2016

    2. Management Responsibilities

    3. Management Reviews

    4. QUIZ: ISO 13485:2016

    1. Requirements for a QMS

    2. QUIZ: Additional Requirements in QMSR

    1. How QMSR Impacts You

    2. QUIZ: How QMSR Impacts You

About this course

  • $129.00
  • 21 lessons
  • 0.5 hours of video content

Don't risk non-compliance.

This new FDA final rule will become a U.S. regulation soon.

Enroll today