FDA QMSR Requirements Training

995.00
4.3 ★★★★★ 67 Reviews
RAPS Cretified Course

FDA QMSR Requirements Training for Practitioners and Auditors 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 (Revised Part 820).

What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. 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.

This course is an internationally accredited credential. The Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants and RAPS credits for members.

FDA QMSR Requirements Training

Overview of our FDA QMSR Requirements Training

Approved By
Regulatory Affairs Professionals Society (RAPS)
RAPS Credits
12
Duration
16hrs
eLearning Access
365 Days
Teaching Format
eLearning
Course Entry Requirements
Prior knowledge is recommended
Certification on Completion
Issued in 1 business day
Course Content Based on
FDA QMSR and ISO 13485
Course Last Updated
February 2026
Language (s)
English
995.00 / Seat
Sample Certificate of FDA QMSR Requirements Training
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands

What's covered on our FDA QMSR Requirements Training

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

eLearning
  • History of the QMSR
  • QMSR Structure
  • QMSR Scope
  • Definitions
  • QMSR and ‘Risk’
  • Introduction to ISO 13485
  • Terms and Definitions
  • Plan-Do-Check-Act
  • Documentation Requirements
  • Process Based QMS
  • Risk Based Thinking (RBT)
  • Management Commitment
  • Related Standards

Case Study! Terms and Definitions

Case Study! KPIs

Case Study! Risk Management and Supplier Qualification

  • Establishing a Quality Management System (QMS)
  • QMS Documentation
  • Assessing for Conformity

Case Study! Software Validation

Case Study! Complaint Handling Records

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

Case Study! Quality Objectives

Case Study! Management Review

  • Provision of Resources
  • Infrastructure & Work Environment
  • Assessing for Conformity

Case Study! Infrastructure and Equipment Maintenance

  • Planning
  • Customer Related Processes
  • Design & Development
  • FDA Device Classification & Regulatory Controls
  • Assessing for Conformity

Case Study! Risk Management

Case Study! Customer Related Processes

Case Study! Design Planning

  • Purchasing
  • Production & Service
  • Control of Monitoring & Measuring
  • Assessing for Conformity

Case Study! Purchasing

Case Study! Calibration Requirements

  • MAI Overview
  • Monitoring & Measuring
  • Control of Nonconforming Product
  • Data Analysis and CAPA
  • Assessing for Conformity

Case Study! Feedback

Case Study! Audit Records

Case Study! Audit Management

Case Study! Incoming Inspection

About our eLearning
 
Regulatory Affairs Professionals Society (RAPS) Recognized Training
Industry-leading eLearning Methodology
Up-to-date Technical Content & Examples
Practical Case Studies based on Real-World Scenarios
More Flexibility & More Savings vs Other Providers
Course Access for 12 Months
Ask The Instructor
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+
  • Understand how the FDA QMSR has evolved to align with ISO 13485 more closely
  • Outline the structure, content & requirements of both the FDA QMSR and ISO 13485
  • Understand the key similarities and differences between the FDA QMSR and ISO 13485
  • Detail the specific quality management-related requirements of the FDA QMSR and ISO 13485
  • Understand how auditors approach Quality Management System Audits to ensure compliance with the FDA QMSR and ISO 13485

This course would be targeted at:

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

RAPS Approved Provider Logo

The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (12).

Upon successful completion, each Learner shall receive a digital Certificate of Achievement 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

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.

Need Corporate, In-House or Customized Training?

Comply Guru offers corporate, in-house and customized training solutions for your organization’s specific needs.

Speak with an experienced member of our team today to learn how we can help.

Frequently Asked Questions

Each license is for 12 months. Upon completion, the module content is still accessible for the full duration. However, the assessments cannot be re-completed once successfully passed (or if you exceed 3 attempts).

Each Learner has a maximum of 3 attempts at each assessment. We strongly encourage all learners to review & revise the course content again before each attempt (if unsuccessful on an attempt).

If unsuccessful after a 3rd attempt, you will not be eligible for certification. No refunds are possible due to a failed examination result.

If you register on the website, you will be able to access the eLearning within 1 hour of registering, subject to successful payment. If you are registering via Purchase Order, access will be enabled within 1 business day of payment being received.

Yes, we offer discounts for 5 or more learners on a scale based on the total number at the time of purchase. If you want to enquire about discounts, request a quote using the form on this page and a member of our team will be in touch.

Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print from your learner dashboard.

Please note: no certificates are available without full payment on file.

Yes, we permit substitutions provided the license has not been activated and the request is made within 30-days of the purchase date. There is no fee for substitutions.

Comply Guru do not provide learners with copies of international standards, nor do we require that any purchase is made. However, participants do need to have access to a copy of required standard(s) on this training, if the credential requires it.

Firstly, we suggest seeing if you can obtain a copy of the required standard(s) from a friend, colleague or at your workplace. If you are unable to do so, each country has a nominated ISO standard supplier where you may purchase the international standard(s) you need for your training.

The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic, and has been independently verified by a globally recognized professional body, i.e. CQI and IRCA, RAPS, or Exemplar Global.

In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.

Extensions to the eLearning deadline (or license) are reviewed on a case by case basis. If you require an extension, please contact our team outlining your reason for the extension in advance of the expiration. Expired licenses cannot be reactivated or extended.

To complete this course successfully, you will need to fully complete each module and obtain 70% or higher in the applicable assessment(s).

All graded assessments are MCQ-based.

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.

NEW GENERATION
of eLearning

Upskill Anytime,
Anywhere

Flexible learning with courses that can be completed at your own pace and schedule

Explorative and
Interactive

Learners are required to explore and interact, not just sit and listen to videos or PowerPoint presentations

Clear and
Engaging Design

Modules crafted by experienced graphical & instructional designers that are easy to follow, will keep your attention and are well structured

Experiential
Learning

A method that involves actively engaging through experience and reflection, helping Learners connect theory to real-world situations

Diversity for Various
Learning Styles

Not everyone learns the same. Our approach incorporates a multi-tier approach to ensure inclusivity for a variety of different learning styles

Checkpoint Activities
and Knowledge Checks

Regular, in-module quizzes, exercises, and case studies to reinforce learning and verify understanding

NEW GENERATION
of eLearning

Upskill Anytime,
Anywhere

Flexible learning with courses that can be completed at your own pace and schedule

Explorative and
Interactive

Learners are required to explore and interact, not just sit and listen to videos or PowerPoint presentations

Clear and
Engaging Design

Modules crafted by experienced graphical & instructional designers that are easy to follow, will keep your attention and are well structured

Experiential
Learning

A method that involves actively engaging through experience and reflection, helping Learners connect theory to real-world situations

Diversity for Various
Learning Styles

Not everyone learns the same. Our approach incorporates a multi-tier approach to ensure inclusivity for a variety of different learning styles

Checkpoint Activities
and Knowledge Checks

Regular, in-module quizzes, exercises, and case studies to reinforce learning and verify understanding

Training Transformed with Comply Guru

Comply Guru has helped organizations reduce training costs by up to 50%, accelerate workforce development, and create sustainable business value through innovative learning solutions.

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.