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United StatesEU MDR Auditor Training for the European Medical Device Regulation (2017/745)
EU MDR Auditor Training to provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.
Our industry-leading blended methodology requires Learners to first complete interactive eLearning modules on the underlying theory that better prepares them before attending Live Classes with an Instructor that focus on practical application in a real life context.
Please note: There are important prior learning requirements to be eligible to attend this course. See Entry Criteria below for more information.
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Gain an Accredited EU MDR Auditor Qualification
Advance your knowledge and enjoy more flexibility & learning effectiveness with blended learning.
Our Methodology
How Blended Learning Works
Blended learning is a two-step approach: Beginning with eLearning modules to grasp the foundational theory, then attending live, instructor-led classes emphasizing practical, real-world application.
Course Structure Explained
Detailed Breakdown & Agenda
Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.
| Time | Topic |
|---|---|
| 90mins eLearning | Module 1: Introduction to the EU MDR
|
| 120mins eLearning | Module 2: Placing a Device on the Market
|
| 90mins eLearning | Module 3: Post Market Surveillance and Vigilance
|
| 120mins eLearning | Module 4: Technical Documentation, UDI and EUDAMED
|
| 60mins eLearning | Module 5: EU MDR Auditing
|
| 40mins | eLearning Exam
|
| Time | Topic |
|---|---|
| 09:00 - 10:00am EST |
Practical Workshop Device Classification |
| 10:00 - 10:10am EST | Break |
| 10:10 - 11:10am EST | Practical Workshop Device Classification, continued |
| 11:10 - 11:25am EST | Break |
| 11:25am - 12:30pm EST | Practical Workshop Medical Device Conformity Assessment Routes |
| 12:30 - 1.15pm EST | Lunch |
| 1:15 - 2:15pm EST | Audit Lifecycle Practical Workshop Simulated Case Study |
| 2:15 - 2.25pm EST | Break |
| 2:25 - 3:30pm EST | Practical Workshop Simulated Case Study, continued |
| 3:30 - 3:45pm EST | Break |
| 3:45 - 5:00pm EST | Practical Workshop Simulated Case Study, continued Exam Preparation End of Day Wrap Up |
| Time | Topic |
|---|---|
| 09:00 - 10:00am | Day 1 Recap |
| 10:00 - 10:10am | Break |
| 10:10 - 11:10am | Practical Workshop Reporting Audit Findings |
| 11:10 - 11:25am | Break |
| 11:25am - 12:30pm | Practical Workshop Reporting Audit Findings, continued |
| 12:30 - 1.15pm | Lunch |
| 1:15 - 2:15pm | Practical Workshop Report and Close |
| 2:15 - 2.25pm | Break |
| 2:25 - 3:30pm | Practical Workshop Audit Follow Up |
| 3:45 - 4:30pm |
|
| Time | Topic |
|---|---|
| 10:00am - 12.30pm | Certification Exam (via eAssessment) |
Course Overview
EU MDR Auditor Training
Explain the background and purpose of a medical device quality management system (MD-QMS) in the context of EU MDR 2017/745 and confirm links with ISO 13485.
Explain the role and responsibilities of an auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 19011/ISO 17021 that uses the EU MDR 2017/745 requirements as the audit criteria.
Plan for and conduct an audit of a medical device quality management system to establish compliance with the EU MDR 2017/745 in accordance with ISO 19011/ISO 17021 as applicable and report on any nonconformities.
CQI & IRCA certify this course (No. 2696). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
Prior to attending this course, learners are expected to have the following prior knowledge:
EU MDR
- A good understanding of the EU MDR (2017/745) requirements and their application is required for this course. This may be gained by successfully completing CQI and IRCA Certified MD-QMS Comprehensive EU-MDR 2017/745 Practitioner (PT219) course. A copy of the training certificate will be requested for verification purposes as part of acceptance onto the course.
Please note: if no recognized certificate is provided, additional information & a pre-course test may be required to verify knowledge of the requirements in order to be accepted onto the course.
ISO 13485
- Must have successfully completed a CQI and IRCA Certified MD-QMS ISO 13485 Lead Auditor course or equivalent. A copy of the training certificate will be requested for verification purposes as part of acceptance onto the course.
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- The process approach used in quality management.
- A working knowledge of risk-management principles related to the design of a medical device, through ISO 14971.
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) by the required deadline set in advance of the given workshop dates you are registered for.
- Fully attend the Instructor Workshops as 100% attendance is required.
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
- Pass the end of course final assessment.
For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the 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
Why Choose Comply Guru's Blended Learning?
Learn about how our Blended Learning Methodology is leading the industry for innovation & learning effectiveness
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.9
Average Rating
14 global ratings
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Overall I think this course was excellent.
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Very engaging, comprehensive detail on topic, great interactive class discussion, flexible but also encouraged full participation by all involved.
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It has met my expectations. Thank you
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I continue to be impressed by the extensive experience and high expertise of the ComplyGuru instructors!
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Excellent course overall - blended learning was very effective!
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