Global
Ireland
Finland
United Kingdom
United StatesQMS 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.
Download Brochure
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 Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System
FEATURED CUSTOMER
How Skeletal Dynamics switched to Online Learning & saved 50% on MedTech QARA Training
FEATURED CUSTOMER
How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training
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 Instructor
Michelle Keane
Our Training Specialist
Eoin Philip Kelly
Course Overview
QMS Software Validation Training
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 course, each Learner will need to:
- Complete all eLearning 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.
Watch and Learn More
About our eLearning
Learn about how our eLearning is leading the industry for innovation through online learning
Related Training Courses
