QMS Software Validation Training

This course introduces the fundamentals of QMS Software Validation in the medical device industry, with a focus on conformance with ISO 13485:2016 and compliance with FDA expectations (21 CFR Part 11, 820.70(i)).

You’ll learn what software validation is, why it matters, and how to apply a risk-based approach to ensure software used in the quality system is fit for its intended use.

Designed as an introductory/induction level course, it provides practical examples, regulatory context, and common pitfalls so organizations can strengthen compliance and be audit ready.

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.

Overview of our QMS Software Validation Training

Approved By

Comply Guru

Duration

60mins

eLearning Access

6 Months

Teaching Format

eLearning

Certification on Completion

Yes

Language (s)

English

Trusted By Notified Bodies & Global Brands

What's covered on our Introduction to QMS Software Validation Training

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

About our eLearning

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.

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.

More Flexibility & More Savings vs Other Providers

Industry-leading eLearning Methodology

Scalable Learning for Teams

Course Access for 6 months

Quick Enrolment within 1hr

Manager Accounts for Groups of 10+

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

Define QMS Software validation and explain its importance
Identify the regulatory requirement under ISO 13485, FDA, and related standards (ISO/TR 80002-2:2017)
Apply the principles of a risk-based approach to software validation
Outline the validation lifecycle: planning, testing, documenting, maintaining
Recognize common pitfalls and prepare for auditor/inspector expectations

This course is for individuals or organizations who want to understand QMS Software Validation in the Medical Device Industry.

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

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

Complete the eLearning course modules and obtain 70% or higher in the final assessment (MCQ-based)

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.

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.

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.

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.

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

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

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

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