ISO 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 Snapshot
 
Approved By
CQI & IRCA (No. 2589)
Duration
12hrs
Available Format
eLearning
Language (s)
English
Price
GBP £  895.00
Learner Rating
★★★★★ 31 Reviews
Why Choose Comply Guru?
Globally Recognized Qualification
Learn Anywhere, Anytime
Course Access for 6 Months
Ask The Instructor
Minimize Downtime at Work
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+

Course Overview

ISO 13485 and FDA QSR 21 CFR Part 820 Foundation

Learning Objectives Covered

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

What This Course Covers

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
Who Should Attend

This course would be targeted at:

  • Quality Engineers
  • Quality Specialists
  • Internal Auditors
  • Quality Managers
  • Regulatory Professionals
Course Accreditation & Certificate
What Are The Entry Requirements

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
How Will You Be Assessed

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)
What Are The Technology Requirements

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Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, a new course license is required (fee applies).
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
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.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Approved Training Provider

CQI & IRCA Approved Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020