EU 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.

Why Choose Comply Guru?

Highly Interactive, Engaging Experience

Accelerated 'Learn By Doing' Methodology

Live Workshops led by Experienced Lead Auditors

Practical Exercises & Collaborative Learning

Course Snapshot

Approved By

Comply Guru

Duration

20hrs

Teaching Format

Live Instructor-led Learning

Delivery Options

Virtual or In-Person Workshops

Language (s)

English

Why Choose Comply Guru?

Highly Interactive, Engaging Experience

Accelerated 'Learn By Doing' Methodology

Live Workshops led by Experienced Lead Auditors

Practical Exercises & Collaborative Learning

Course Structure Explained

Detailed Breakdown & Agenda

Attend live, instructor-led workshops emphasizing practical, real-world application.

Time	Topic
09:00 - 10:00am	Course Introduction Regulatory Pathway 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 Practical Workshop Simulated Case Study, continued
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	Exam Preparation (Q&A) Course Wrap Up Course Survey

Time	Topic
10:00am - 12.30pm	Certification Exam (via eAssessment)

Course Overview

EU IVDR Auditor Training

Learning Objectives

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.

Course Certification

Upon successful completion, each Learner shall receive a digital Certificate of Achievement.

What Are The Entry Requirements

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.

How Will You Be Assessed

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.

What Are The Technology Requirements

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.

Why Choose Instructor led Learning

Frequently Asked Questions

Can I transfer my place to a colleague?

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.

Can I transfer to different workshop dates?

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.

Do we offer group discounts?

Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.

Do we offer in-house / private training?

Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.

What if I fail the eLearning assessment, what happens?

Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, you will not be eligible to continue to the live workshops.

What is the maximum number of learners in the live workshops?

We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.

Related Training Courses

EU IVDR Training for Practitioners working with the European In Vitro Diagnostic Regulation (2017/746)

EU IVDR Auditor Training for the European In Vitro Diagnostic Regulation (2017/746)

Detailed Breakdown & Agenda

EU IVDR Auditor Training

About our EU IVDR Auditor Training

EU IVDR Training for Practitioners

Advanced EU IVDR Practitioner

ISO 13485 Lead Auditor Training