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United StatesEU MDR Training for Practitioners working with the European Medical Device Regulation (2017/745)
EU MDR Training for Practitioners that takes you through the new European Medical Device Regulation (2017/745), not just from an industry perspective, but also from a Notified Body perspective. This course has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
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Course Structure Explained
eLearning Module Breakdown & Timings
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
| Time | Topic |
|---|---|
| 90mins eLearning | Module 1: Introduction to the EU MDR
|
| 95mins eLearning | Module 2: Medical Devices covered by the EU MDR
Case Study! Medical Device Scope Case Study! Scope and Legacy Devices |
| 175mins eLearning | Module 3: Placing a Device on the Market
Case Study! Qualifications of the PRRC Case Study! Change of Authorized Representative Case Study! Declaration of Conformity Case Study! A PRRC under Pressure |
| 45mins | Certification Exam 1 of 3
|
| 160mins | Module 4: Device Classification
Case Study! Device Classification |
| 160mins | Module 5: Routes to Conformity
Case Study! Route to Conformity |
| 150mins | Module 6: GSPR and Risk Management
Case Study! GSPRs 1 – 8 |
| 45mins | Certification Exam 2 of 3
|
| 160mins | Module 7: Clinical Evaluation
Case Study! Excerpt of a CER for Review |
| 150mins | Module 8: Post Market Surveillance and Vigilance
Case Study! Periodic Safety Update Report |
| 145mins | Module 9: Technical Documentation, UDI and EUDAMED
|
| 45mins | Certification Exam 3 of 3
|
Course Overview
EU MDR Training for Practitioners
Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
Identify the types of devices covered by the EU MDR and the rules for classifying these devices
Describe the obligations of the economic operators and the PRRC
Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
Explain the Unique Device Identifier requirements and the relationship with EUDAMED
This course has been designed for those working in Quality Assurance and/or Regulatory Affairs who want to gain a better understanding of the EU Medical Device Regulation (EU MDR 2017/745), including:
- Quality Assurance Professionals
- Quality Engineers
- Research and Design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
CQI & IRCA certify this course (No. 2378). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.
Before completing this course, each Learner should have the following prior knowledge:
- A working knowledge of ISO 13485, which may be gained by completing Comply Guru’s ISO 13485 Foundation Course
- The relationship between ISO 13485 and the EU MDR 2017/745
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
- A working knowledge of risk management principles related to the design of a medical device, through ISO 14971
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (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.
Why Choose Comply Guru
About Our Training for Practitioners
Learn about how our IRCA Certified MDR Training for Practitioners is leading the industry for innovation through online learning
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.6
Average Rating
329 global ratings
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Useful to be able to access content at a time that suits the learner.
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Full of information
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The overall training experience was too good, definitely enhanced my skills and knowledge.
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Efficient service. Relevant and knowledgeable topics on offer. Practical training to support professionals.
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The exam times of 45 minutes was too short and add undue pressure.
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