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United StatesEU IVDR Lead Auditor Training for the European In Vitro Diagnostic Regulation (2017/746)
EU IVDR Lead 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.
During live workshops, our experienced Instructors will use practical training methods with real-world examples, case studies, facilitated exercises and group discussions. Upon completion, Learners will be equipped to make an instant impact with their newly acquired knowledge and skills.
Overview of our EU IVDR Lead Auditor Training
What's covered on our EU IVDR Lead Auditor Training
Attend live, instructor-led workshops emphasizing practical, real-world application.
- Course Introduction
- Key Terminology Recap
- Audit Types
- Audit Objective, Scope Criteria
Practical Workshop Audit Objective, Scope & Criteria
- Audit Personnel
- Audit Methods
- Audit Frequency
Practical Workshop Device Classification
Practical Workshop Device Conformity Assessment Routes
- Audit Lifecycle
Practical Workshop Simulated Case Study
Day 1 Recap
Practical Workshop Simulated Case Study, continued
Practical Workshop Reporting Audit Findings
Practical Workshop Report and Close
Practical Workshop Audit Follow Up
Upon successful completion of the live workshops, learners are eligible to self-register for a bi-monthly CQI & IRCA certification exam (completed remotely) from their learner dashboard.
Michelle Keane
Tess Egan
- 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 utilize Microsoft Teams and SharePoint.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
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Frequently Asked Questions
Yes, very practical. Our live workshops are based on the principles of Accelerated Learning (AL). AL is based on ‘learn by doing’ through practical training methods which include real-world examples, case studies, facilitated exercises and group discussions.
We are passionate about ‘No Death by PowerPoint’ or a ‘sit and listen’ methodology. In fact, there are no slides during the live workshops. Come prepared to be fully engaged and of course, to learn a lot!
Yes, we can deliver training in-person or onsite for in-company groups. However, all our public training is delivered virtually. If you prefer in-person training, get in touch, we are happy to help.
Yes, we offer in-company training provided you have 5 or more learners that can be trained together on the same dates. Please request a quote and a member of our team will be in touch to discuss this further with you.
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.
Please note: no certificates are available without full payment on file.
Yes, we permit substitutions provided the license has not been activated, the substitute meets the entry criteria and there is sufficient time available for the replacement to complete the mandatory eLearning and assessments. There is no fee for substitutions.
If the workshop is delivered virtually, there will be a link on your Learner dashboard. This link will become a visible two days in advance of the start date. In addition, a calendar invite is issued.
Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.
Comply Guru do not provide learners with copies of international standards, nor do we require that any purchase is made. However, participants do need to have access to a copy of required standard(s) on this training.
Firstly, we suggest seeing if you can obtain a copy of the required standard(s) from a friend, colleague or at your workplace. If you are unable to do so, each country has a nominated ISO standard supplier where you may purchase the international standard(s) you need for your training.
Once you have fully attended the live workshop(s) and passed the assessments you will be able to register for the lead auditor exam via your learner dashboard by selecting one of our scheduled exam dates. The exams are attended remotely.
Lead auditor exams must be graded by two examiners, and the process takes up to 30 days to be completed.
Yes, you can reschedule your exam. This can be done via your learner dashboard. We require a minimum of 48 hours’ notice to reschedule.
If you are unsuccessful in your first attempt, you will be able to schedule a resit exam. There is a limit of 1 resit available. If you are unsuccessful in your second attempt, you would need to re-register and re-complete the full training, plus a new exam (subject to additional fees).
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What Our Learners Are Saying
4.7
Average Rating
19 global ratings
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The training broadens up my learning objectives of the vast requirement for the IVDR. The instructor able to teaches and answer every question due to the experience had. The training was fun. To make sure participants know and understand the regulations, group training was also included.
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The training was very well organized and clearly structured. It provided valuable insights into key topics. The trainer was highly engaged throughout the session, addressed topics beyond the planned agenda, and answered all questions professionally and thoroughly, which added significant value.
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The training was well structured and aligned well with EU IVDR requirements. The instructor was knowledgeable and interactive. Overall, an excellent leaning experience.
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The training was very well structured and easy to understand and follow. The overall experience, while challenging, I found enjoyable and extremely valuable.
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The extra time allotted for the course due to the file access challenge was very much appreciated. The course content was delivered clearly and the trainor was very knowledgeable on the subject matter.
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