EU MDR Internal Auditor Training for the European Medical Device Regulation (2017/745)

Name: No More Death By PowerPoint
Uploaded: 2025-04-07T12:08:10+00:00
Duration: 87.6667
Description: Our courses are designed with practical exercises that have Learners working with scenarios, case studies and material that is focused on a ‘learn by doing’ approach.

97% Recommended from 6K+ Learners

EU MDR Internal Auditor Training for existing ISO 13485 Internal or Lead Auditors seeking the knowledge & skills to perform internal audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU MDR 2017/745) in accordance with ISO 19011.

Our live learning methodology focuses on practical ‘learn by doing’ workshops set in a real life context.

EU MDR Internal Auditor Training for the European Medical Device Regulation (2017/745)

Course Snapshot

Approved By

Comply Guru

Duration

7hrs

Teaching Format

Live Learning

Delivery Options

Virtual or In-Person

Certification on Completion

Yes

Language (s)

English

View Sample Certificate of Achievement

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

Have 5 or more that need training?

We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

FEATURED CUSTOMER

How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

"Comply Guru’s trainers are not only experienced in their specific fields but are also experts in the art of training. By using a provider who integrates modern self-study e-learning methods with traditional in-person sessions, we can be confident that our learning outcomes are maximized."

Zoran Klaric

Manager Regional Training & Onboarding

FEATURED CUSTOMER

How Skeletal Dynamics switched to Online Learning & saved 50% on MedTech QARA Training

“Over the years, I have used many well-known U.S training providers, but I found Comply Guru had truly mastered ‘online’ training which has saved Skeletal Dynamics over 50% in training fees, associated expenses as well as 100% of the time lost spent travelling to training with other providers.”

Mario Arbesu

VP of Quality Assurance & Regulatory Affairs

Our Methodology

No More Death By PowerPoint

Our courses are designed with practical exercises that have Learners working with scenarios, case studies and material that is focused on a ‘learn by doing’ approach.

Course Structure Explained

Detailed Breakdown & Agenda

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

Time	Topic
1.00pm	Course Introduction Welcome and Learner Attendance Learning Outcomes Overview Key MDR Requirements not covered in ISO 13485:2016
2.00pm	Break
2.10pm	Audit Preparation – Document Review How to review documents in advance of an MDR Internal Audit
3.10pm	Break
3.20pm	Audit Preparation – Plan & Checklist Developing an MDR-focused audit plan and audit checklist
4.20pm	Break
4.30pm	MDR Based Audit Scenarios Scenario-based activity to analyze audit situations and identify MDR related nonconformities Summary of Day 1 Key learning points and group discussion
5.30pm	Close

Time	Topic
1:00pm	Audit Findings & Report Writing Writing clear audit findings linked to MDR clauses. Generating the Audit Report
2.00pm	Break
2.10pm	Follow-up Activities How to manage corrective actions, assess effectiveness, and consider regulatory implications
3.10pm	Break
3.20pm	Scenario Based Exercise – Audit Findings & Report Participants develop audit findings and a short report based on an MDR Case Study
4.20pm	Break
4.30pm	Final Exam 30-minute written exam Course Close w/key takeaways
5.30pm	Close

Our Experts

Meet the Instructors

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.

Our Instructor

Tess Egan

Tess is a former Regional Compliance Auditor for Abbott Rapid Diagnostics Division responsible for the planning and execution of independent Regional Compliance audits for Divisional regulated entities in the EMEA region.

Course Overview

EU MDR Internal Auditor Training

Key Features Covered

Live Learning from Anywhere

Up-to-date Technical Content & Examples

Practical Case Studies based on Real-World Scenarios

Practical Workshops led by Experienced Lead Auditors

Learning Objectives Covered

Explain the role and responsibilities of an internal auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 19011 that uses the EU MDR 2017/745 requirements as the audit criteria.

Plan for and conduct an internal audit of a medical device quality management system to establish compliance with the EU MDR 2017/745 in accordance with ISO 19011 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 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.

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 recognized MD-QMS ISO 13485 Internal or Lead Auditor course or equivalent.

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.

Watch and Learn More

About our EU MDR Internal Auditor Training

Learn about the benefits and key features of Comply Guru’s Instructor led Learning.

Why Choose Instructor led Learning

Frequently Asked Questions

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 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.

What payment methods do we accept?

The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com

When and where do I get my course certificate?

Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

Related Training Courses

EU MDR Lead Auditor Training for the European Medical Device Regulation (2017/745)