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United StatesEU IVDR Auditor Training for the European In Vitro Diagnostic Regulation (2017/746)
EU IVDR 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 In Vitro Diagnostic Regulation (EU IVDR 2017/746) in accordance with ISO 19011 and ISO 17021, as applicable.
Our blended learning methodology is a hybrid approach where Learners first complete eLearning modules on the underlying theory that better prepares them in advance of attending Live Classes with an Instructor that focus on practical application in a real life context.
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Course Structure Explained
Detailed Breakdown & Agenda
Attend live, instructor-led workshops emphasizing practical, real-world application.
| Time | Topic |
|---|---|
| 09:00 - 10:00am |
Practical Workshop Device Classification |
| 10:00 - 10:10am | Break |
| 10:10 - 11:10am | Practical Workshop Device Classification, continued |
| 11:10 - 11:25am | Break |
| 11:25am - 12:30pm | Practical Workshop Medical Device Conformity Assessment Routes |
| 12:30 - 1.15pm | Lunch |
| 1:15 - 2:15pm | Audit Lifecycle Practical Workshop Simulated Case Study |
| 2:15 - 2.25pm | Break |
| 2:25 - 3:30pm | Practical Workshop Simulated Case Study, continued |
| 3:30 - 3:45pm | Break |
| 3:45 - 5:00pm | 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 IVDR Auditor Training
Explain the background and purpose of a medical device quality management system (MD-QMS) in the context of EU IVDR 2017/746 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 IVDR 2017/746 requirements as the audit criteria.
Plan for and conduct an audit of a medical device quality management system to establish compliance with the EU IVDR 2017/746 in accordance with ISO 19011/ISO 17021 as applicable and report on any nonconformities.
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 IVDR
- A good understanding of the EU IVDR (2017/746) requirements and their application is required for this course. This may be gained by successfully completing our EU-IVDR 2017/746 Practitioner 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:
- 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
About our EU IVDR Auditor Training
Learn about the benefits and key features of Comply Guru’s Instructor led Learning.
