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United StatesEU Regulations Essentials
Comply Guru offer both a European Medical Device Regulation (EU MDR 2017/745) Essentials Course and/or a European In Vitro Diagnostic Regulation (EU IVDR 2017/746) Essentials Course for organizations looking for a concise, high-level introduction for their staff. These courses are exclusively offered to in-company groups.
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Course Overview
EU Regulations Essentials
Our 2hr 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.
eLearning
On completion of the MDR essentials course, successful Learners will have the knowledge needed to:
- Explain the history, purpose, and structure of the EU MDR
- Describe the key changes to the EU MDR from the MDD
- Identify the different roles and responsibilities associated with the EU MDR
- Outline the requirements for placing a medical device on the market
On completion of the IVDR essentials course, successful Learners will have the knowledge needed to:
- Explain the history, purpose, and structure of the EU IVDR
- Describe the key changes to the EU IVDR from the IVDD
- Explain what an IVD medical device is
- Describe the types of IVD devices that are covered by the regulation
- Outline some other key aspects of the new EU IVDR
These courses are for organizations who wish to provide their staff with a short, general overview of either the EU MDR and/or EU IVDR. There is a minimum order requirement for this training.
Please note, these are separate courses per EU regulation (not combined).
Successful completion 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.
Pricing
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Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.8
Average Rating
223 global ratings
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Great training session! Content was very useful and well delivered. Thank you for a great course. Great presentation style and looking forward for further trainings
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The training is very clear and the interface works well. The information provided allows for a good comprehension of the basis for MDR.
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Very informative
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Navigation within the training course was easy to follow, initial set up of account was very easy also.
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The content was very well organized in chapters and easy to follow. The questions helped for the comprehension and the summary of each chapter. The people were very helpful. Overall, an excellent impression of the training experience!
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