ISO 13485 and FDA QSR 21 CFR Part 820 Foundation for Practitioners and Auditors

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.

CQI-IRCA Cretified Course
ISO 13485 and FDA QSR 21 CFR Part 820 Foundation for Practitioners and Auditors
 
Course Snapshot
Approved By
CQI & IRCA (No. 2589)
Duration
12hrs
Teaching Format
eLearning
Language (s)
English
Learner Rating
★★★★★ 34 Reviews

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We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

Our Methodology

Not all eLearning is the same

Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. We deploy a multi-layered methodology that offers you a New Generation of eLearning.

Not all eLearning is the same
Not all eLearning is the same
 

Course Structure Explained

eLearning Module Breakdown & Timings

An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.

Time Topic
100mins eLearning

Module 1 – Introduction to the FDA QSR and ISO 13485

  • FDA QSR: History, Purpose and Application
  • ISO 13485: Purpose, History and Benefits
  • FDA QMSR Adoption
  • CFR Part 820 Structure
  • ISO 13485 Structure
  • Terms and Definitions
  • Plan-Do-Check-Act
  • Process Approach
  • Risk Management and Medical Devices
90mins eLearning

Module 2 – Establishing a Quality Management System

  • Establishing a Quality Management System (QMS)
  • Software Validation
  • Documentation Requirements & Document Control
  • Record Control under FDA QSR
  • Assessing for Conformity
60mins eLearning

Module 3 – Management Responsibility

  • Management Commitment & Customer Focus
  • Quality Policy, Objectives & Planning
  • Responsibility, Authority & Communication
  • Management Review
  • Assessing for Conformity
60mins eLearning

Module 4 – Resource Management

  • Provision of Resources
  • Human Resources
  • Infrastructure & Work Environment
  • Assessing for Conformity
90mins eLearning

Module 5 – Product Realization, Part 1

  • Planning
  • Customer Related Processes
  • Design & Development
  • FDA Classification and Regulatory Controls
  • Assessing for Conformity
75mins eLearning

Module 6 – Product Realization, Part 2

  • Product Realization
  • Purchasing
  • Production & Service
  • FDA QSR Labeling and Packaging
  • FDA QSR Additional Servicing Requirements
  • Control of Monitoring & Measuring
  • Reference Instruments
  • Assessing for Conformity
75mins eLearning

Module 7 – Measurement, Analysis, and Improvement

  • MAI Overview
  • Monitoring & Measuring
  • Complaint Handling and Reporting
  • Manufacturer Investigation and 21 CFR Part 803
  • Regulatory Reporting
  • Post Market Surveillance (PMS)
  • Internal Audits
  • Control of Nonconforming Product
  • NC Product Handling and Rework
  • Data Analysis and CAPA
  • Assessing for Conformity
45mins

Certification Exam

  • 40 MCQ-based eAssessment with 70% or higher required to achieve certification

Our Experts

Meet The People Behind The Course

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Michelle Keane

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.
Leon Donnellan

Our Graphical & Instructional Designer

Leon Donnellan

Leon has over 20 years of experience in eLearning. During his illustrious career, he has spent 10+ years designing programs within highly regulated industries. He brings vast experience to Comply Guru in both graphical and instructional design.
Eoin Philip Kelly

Our Training Specialist

Eoin Philip Kelly

Eoin has almost 20yrs of experience in internationally accredited training design & delivery. He founded Comply Guru to pursue his vision to bridge the major gap in the market for learning solutions that were more accessible, convenient & flexible in a fast-changing world of International Standards & Medical Device Regulations.

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

Who Should Attend

This course would be targeted at:

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

CQI IRCA

CQI & IRCA certify this course (No. 2589). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.

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

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.

Who Choose Our eLearning?

Learn about how our eLearning methodology is leading the industry for innovation through online learning

 
Why Choose eLearning

What Our Learners Are Saying

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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.
Globally Recognized Qualifications
Training credentials that you can trust.
CQI & IRCA Approved Training Provider
Exemplar Global Recognized Training Provider
RAPS Recertification Approved Provider