FDA QMSR Essentials Training

97% Recommended from 6K+ Learners

Comply Guru offer a FDA QMSR Essentials Course for individuals or organizations looking for a concise, high-level introduction.

Our Essentials training courses are 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.

Course Snapshot

Approved By

Comply Guru

Duration

1.5hrs

Course Access

30-days

Teaching Format

eLearning

Certification on Completion

Available for Purchase

Language (s)

English

Certification Fee

€195.00

No Card Required

View Sample Certificate of Completion

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

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.

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

VP of Quality Assurance & Regulatory Affairs

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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

Manager Regional Training & Onboarding

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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.

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.

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.

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.

Course Overview

FDA QMSR Essentials

Key Features Covered

More Flexibility & More Savings vs Other Providers

Industry-leading eLearning Methodology

Scalable Learning for Teams

Free Enrolment and Course Access for 30 days

Quick Enrolment within 1hr

Manager Accounts for Groups of 10+

Learning Objectives

Explain the purpose and scope of the QMSR

Compare the key differences between QMSR and 21 CFR 820

Describe how QMSR aligns with ISO 13485

Recognize the impact of QMSR on Medical Device Manufacturers

Identify basic steps and resources for achieving compliance

Who Should Attend

This course is for individuals or organizations who want a short, general overview of the FDA QMSR.

Course Certificate

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

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.

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

Frequently Asked Questions

Can I buy just 1 license of this Essentials course?

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.

How long does it take to complete the Essentials course?

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.

How long will I have access to the Essentials course?

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.

What if I fail the eLearning assessment, what happens?

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.

What technology is used for this Essentials training?

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.

When and where do I get my Essentials course certificate?

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.

Related Training Courses

FDA QMSR and ISO 13485 Requirements for Practitioners and Auditors