Online ISO 13485 & FDA QSR 21 CFR 820 Training

ISO 13485 & FDA QSR 21 CFR 820 Training | CQI, IRCA & Exemplar Global Certified

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Online ISO 13485 & FDA QSR 21 CFR Part 820 Training that is an expansion of our existing ISO 13485 Foundation eLearning to include the FDA QMSR requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (21 CFR Part 820). Following the FDA’s recent QMSR remodeling proposal to align the current requirements to ISO 13485, this course will explore in detail the relationship between ISO 13485 and FDA Quality System Regulation requirements.

Our 12hr eLearning course is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Subject Area
Medical Devices
12 Hours
USD $ 895.00  per person
Team Pricing
USD $ 3,580.00
CQI & IRCA (No. 2589), Exemplar Global

This Online FDA 21 CFR Part 820 Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere. It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.

Learning Objectives

On completion of this Online ISO 13485 & FDA QSR 21 CFR Part 820 Training, successful Learners will have the knowledge needed to:

  1. Identify and comprehend the basics of the FDA QSR structure, its provisions, and content
  2. Discern the similarities and key differences between the FDA QSR and ISO 13485
  3. Practical application of Quality System Requirements as required by U.S Regulation 21 CFR Part 820 and ISO 13485 requirements
  4. An Insight into the auditor’s approach during Quality Management System audits

Course Content

During the eLearning modules, each Learner will cover the following:

  • Module 1 – Introduction to the FDA QSR 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

Who Should Attend?

This course would be targeted at:

  • Quality Engineers
  • Quality Specialists
  • Internal Auditors
  • Quality Managers
  • Regulatory Professionals

Entry Requirements

It is recommended that each Learner should have the following prior knowledge before completing this course:

Management Systems

  • 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.

Quality Management

  • The fundamental concepts and commonly used quality management terms and definitions

Assessment & Certification

Assessment Methodology

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


CQI, IRCA & Exemplar Global certifies our Online ISO 13485 Foundation including FDA QSR 21 CFR Part 820 Requirements Training (No. 2589). Successful completion will entitle each Learner to receive a digital Certificate of Completion recognized by CQI, IRCA & Exemplar Global.