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Introduction to FDA QMSR Training

4.4 ★★★★★ 20 Reviews
97% Recommended

Comply Guru offer an Introduction to the FDA QMSR for individuals or organizations looking for a concise, high-level introduction.

At the end of this short course, successful learners will be able to:

  • Describe the purpose and scope of the Quality Management System Regulation (QMSR)
  • Explain how the QMSR supports Quality, Safety, and Compliance in Medical Device Manufacturing

Our eLearning 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.

Introduction to FDA QMSR 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
 
Course Snapshot
Learner Rating
4.4 ★★★★★ 20 Reviews
Approved By
Comply Guru
Duration
45mins
eLearning Access
30 Days
Teaching Format
eLearning
Certification on Completion
Issued in 1 business day
Course Content Based on
FDA QMSR
Course Last Updated
August 2025
Language (s)
English
Group or In-House Pricing Have 5 or more?

View Sample Certificate of Completion

Upon successful completion, each Learner shall receive a digital Certificate of Completion.
Sample Certificate of Introduction to FDA QMSR Training

Have 5 or more that need training?

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

How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

FEATURED CUSTOMER

How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

"Comply Guru’s trainers are not only experienced in their specific fields but are also experts in the art of training. By using a provider who integrates modern self-study e-learning methods with traditional in-person sessions, we can be confident that our learning outcomes are maximized."
Zoran Klaric

Zoran Klaric

Manager Regional Training & Onboarding

How Skeletal Dynamics switched to Online Learning & saved 50% on MedTech QARA Training

FEATURED CUSTOMER

How Skeletal Dynamics switched to Online Learning & saved 50% on MedTech QARA Training

“Over the years, I have used many well-known U.S training providers, but I found Comply Guru had truly mastered ‘online’ training which has saved Skeletal Dynamics over 50% in training fees, associated expenses as well as 100% of the time lost spent travelling to training with other providers.”
Mario Arbesu

Mario Arbesu

VP of Quality Assurance & Regulatory Affairs

How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

FEATURED CUSTOMER

How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

“Comply Guru took the stress out of training. Their courses didn’t just tick a box—they added real value to our quality system.”
Bernard Wallace

Bernard Wallace

Quality Affairs Manager

Course Overview

Introduction to FDA QMSR

Key Features Covered
More Flexibility & More Savings vs Other Providers
Industry-leading eLearning Methodology
Scalable Learning for Teams
Course Access for 30 days
Quick Enrolment within 1hr
Manager Accounts for Groups of 10+
Who Should Attend

This course is for individuals or organizations who want a short introduction to the FDA QMSR.

Course Certificate

Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.

How Will You Be Assessed

In order to successfully complete this course, each Learner will need to:

  • Complete all 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.

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
 

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.

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.
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.

Watch and Learn More

About our Essentials Training

Learn about how our FDA QMSR Training is leading the industry for innovation through online learning

 
Why choose eLearning

Customer Reviews

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.

Frequently Asked Questions

Unfortunately not. The Essentials courses are only available for groups of 5 or more. If you would like a quote, please complete a Request Quote form and a member of our team will contact you to discuss this further.
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 30 days (1 month). Access is available 24/7 for the full 30-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, you will not be eligible to continue to the live workshops.
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 assessment, 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.

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