Introduction to ISO 13485 Training
Comply Guru offer an Introduction to ISO 13485 for organizations looking for a concise, high-level introduction for their staff.
At the end of this short course, successful learners will be able to:
- Understand the scope, structure, and benefits of a Medical Device Quality Management System (MD-QMS)
- Describe ISO 13485 and its role in supporting medical device quality and safety
Our eLearning 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.
Overview of our Introduction to ISO 13485
What's covered on our Introduction to ISO 13485 Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
At the end of this short course, successful learners will be able to:
- Understand the scope, structure, and benefits of a Medical Device Quality Management System (MD-QMS)
- Describe ISO 13485 and its role in supporting medical device quality and safety
This course is for organizations who wish to provide their staff with a short, general overview of ISO 13485.
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.
Frequently Asked Questions
No, this micro-credential is only available for groups of 10 or more, or for licensing (annual subscription) on your organization’s Learning Management System (LMS). For more information, visit our licensing page or complete our contact us form 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.
The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic.
In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.
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
Training Transformed with Comply Guru
What Our Learners Are Saying
4.5
Average Rating
384 global ratings
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Very useful.
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Concise and precise. I would have liked more information ragarding SaMDs regulation.
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Good degree of basic info
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Enjoyed the interactive element although for an introduction I would like to have seen more examples of what is contained in each clause.
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This training gives important highlights to anyone who is working with ISO 13485 and planning to dive deeper into audit field.


