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United StatesISO 13485 and FDA QSR 21 CFR Part 820 Foundation Training is for Practitioners & Auditors who want to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (QSR 21 CFR Part 820).
Important Note: This course is based on the current FDA Quality System Regulation (QSR 21 CFR Part 820) that is being replaced by the new QMSR in February 2026. If you want to master the requirements of the new FDA QMSR, you should visit this course page.
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
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Course Overview
ISO 13485 and FDA QSR 21 CFR Part 820 Foundation
Identify and comprehend the basics of the FDA QSR structure, its provisions, and content
Discern the similarities and key differences between the FDA QSR and ISO 13485
Practical application of Quality Management System Requirements as required under the FDA QSR and ISO 13485 requirements
An Insight into the auditor’s approach during Quality Management System audits
During the eLearning modules, each Learner will cover the following:
- Module 1 – Introduction to ISO 13485 & the FDA QSR
- Module 2 – Quality Management System
- Module 3 – Management Responsibility
- Module 4 – Resource Management
- Module 5 – Product Realization, Part 1
- Module 6 – Product Realization, Part 2
- Module 7 – Measurement, Analysis, and Improvement
This course would be targeted at:
- Quality Engineers
- Quality Specialists
- Internal Auditors
- Quality Managers
- Regulatory Professionals
It is recommended that each Learner should have the following prior knowledge before completing this course:
- The Plan, Do, Check, Act (PDCA) cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
- The fundamental concepts and commonly used quality management terms and definitions
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
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Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.5
Average Rating
31 global ratings
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I am very happy that I did the Comply Guru's ISO 13485 + FDA QSR Foundation Training course. It is extremely well designed. The pace is perfect. It gives a clear understanding of ISO 13485, the in-between-the lines meaning of many requirements and then takes you to QSR. There is also a comparison between the standard and the regulation, which is helpful. The content keeps you engaged. Knowledge checks help you gauge how much you have understood. The examples, resources are all up to the mark. An excellent course!! Thank you Comply Guru
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Great course with correct amount of content
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This course does a good job of linking the requirements of ISO 13485 to FDA QSR and provides a clear overview of both standards.
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Comply Guru has been extremely useful, and the self-pace makes it very easy to learn on your own schedule. I plan on taking more classes in the future.
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expectations were fully met
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