FDA 21 CFR Part 820 QMSR 2026 Requirements

ISO 13485 Lead Auditor / U.S. FDA CFR Part 820 QMSR

This bundle includes two courses: ISO 13485:2016 Lead Auditor and U.S. FDA 21 CFR Part 820 QMSR 2026 Requirements.

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U.S. FDA 21 CFR Part 820 QMSR 2026 Requirements [English]-26

This ON DEMAND 2-hour e-course teaches a detailed understanding of the requirements of U.S. FDA 21 CFR Part 820 QMSR 2026 and CGMP regulations for Medical Devices. Includes a Certified Training Certificate of Competence. 0.2 CEUs. Language: English.

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Course curriculum

1. How to use this course
1. SHO-Gap Analysis Checklist-US FDA 21 CFR 820_02-Feb-2026
2. SHO-Quick Reference-U.S. FDA 21 CFR Part 820 QMSR_02-Feb-2026
3. SHO-ISO 13485-2016-Audit Checklist
4. SHO-Top 10 FDA Inspection Observations for Medical Device Establishments
1. FDA-QMSR-2026- Requirements_V03_Lesson01
1. FDA-QMSR-2026- Requirements_V03_Lesson02
1. FDA-QMSR-2026- Requirements_V03_Lesson03
1. FDA-QMSR-2026- Requirements_V03_Lesson04
2. Top 10 FDA Inspection Observations for Medical Devices
1. FDA-QMSR-2026- Requirements_Quiz01
2. FDA-QMSR-2026- Requirements_Quiz02
1. Video-Congratulations-Next Steps

About this course

$950.00
13 lessons
0 hours of video content

ISO 13485 Lead Auditor / U.S. FDA CFR Part 820 QMSR

U.S. FDA 21 CFR Part 820 QMSR 2026 Requirements [English]-26

Course curriculum

Welcome to the course!

Student Handouts

Introduction and Background

Scope of the QSMR

Regulatory Context and Authority

Key Elements of the QMSR: Definitions, Standards, and Core Requirements

Quizs

Next steps

About this course