QMSR Final Rule Implementation Training

QMSR Final Rule Implementation - Medical Device

It's time to implement the new FDA final rule for Quality Management System Regulation (QMSR) for medical device companies. This 1-hour course includes training, downloads and tools to implement. A training certificate is provided upon completion.

Buy $199.00

Course curriculum

1. How to Use This Course
2. Welcome Message
1. What is QMSR?
2. Download QMSR Final Rule
3. QUIZ: Overview
1. 21 CFR 4: Combination Products
2. QUIZ: Combination Products
1. 21 CFR 820.7: Incorporation by Reference
2. Download Free ISO Standards
3. QUIZ: Incorporation by Reference
1. 21 CFR 820.3: Terms and Definitions
2. Download Glossary of Terms and Definitions - Medical Device
3. QUIZ: Terms and Definitions
1. Overview of ISO 13485:2016
2. QUIZ: Overview of ISO 13485:2016
1. 21 CFR 820.10: Requirements for a QMS
2. QUIZ: Requirements for a QMS
1. 21 CFR 820.35: Control of Records
2. QUIZ: Control of Records
1. 21 CFR 820.45: Device Labeling and Packaging Controls
2. QUIZ: Labeling and Packaging Controls
1. Regulatory Considerations
2. QUIZ: Regulatory Considerations
1. Download QMSR Quality Plan / Gap Analysis Template
2. QMSR Final Rule Implementation Steps
1. Rate this Course!
2. QUIZ: Final Rule
3. Wrap-Up

About this course

$199.00
28 lessons
1 hour of video content

Don't risk non-compliance.

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

Enroll today

QMSR Final Rule Implementation - Medical Device

Course curriculum

1 - Welcome to the course!

2 - Overview and Scope of QMSR Final Rule

3 - Combination Products

4 - Incorporation by Reference

5 - Terms and Definitions

6 - Overview of ISO 13485:2016

7 - Requirements for Quality Management System

8 - Control of Records

9 - Labeling and Packaging Controls

10 - Regulatory Considerations

11 - Implementation Steps

12 - Review and Wrap-up

About this course

Don't risk non-compliance.