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United StatesFDA QMSR Training (incl. ISO 13485) is for anyone who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (21 CFR Part 820).
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.
Course Overview
FDA QMSR + ISO 13485 Foundation Training
Identify and comprehend the basics of the FDA QMSR structure, its provisions, and content
Discern the similarities and key differences between the FDA QMSR and ISO 13485
Practical application of Quality Management System Requirements as required by U.S Regulation 21 CFR Part 820 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 the FDA QMSR and its relationship to ISO 13485
- 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
CQI & IRCA certify this course (No. 2589). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.
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) within the 90-day license
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.6
Average Rating
28 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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