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United StatesIntroduction to Quality and Regulatory Affairs in MedTech
Comply Guru offer an Quality and Regulatory Affairs is for individuals or organizations looking for a concise, high-level introduction to the Medical Device Industry.
At the end of this short course, successful learners will be able to:
- Understand what quality means in the medical device industry
- Recognize how different roles contribute to quality and compliance
- Understand the reason for and types of audits and inspections
- Describe how medical devices are classified and regulated around the world
- Understand the role of regulatory affairs
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 Introduction to Quality and Regulatory Affairs
What's covered on our Introduction to Quality and Regulatory Affairs Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
Eoin Philip Kelly
Michelle Keane
At the end of this short course, successful learners will be able to:
- Understand what quality means in the medical device industry
- Recognize how different roles contribute to quality and compliance
- Understand the reason for and types of audits and inspections
- Describe how medical devices are classified and regulated around the world
- Understand the role of regulatory affairs
This course is for individuals or organizations who want a short introduction to Quality and Regulatory Affairs 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.
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
4.8
Average Rating
4 global ratings
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My overall experience with comply guru was excellent.
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Modules are broken down into suitable sizes for both information content and time usage. This gives a very good overview of the topic, good for an overview to see if an individual would like to progress further with these topics. I would recommend usage of this training to others.
