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

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
Individual Price
Request Quote

View Sample Certificate of Achievement

Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
Sample Certificate of EU MDR Internal Auditor Training for the European Medical Device Regulation (2017/745)

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.

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.

No More Death By PowerPoint
No More Death By PowerPoint
 

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

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.

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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
Globally Recognized Qualifications
Training credentials that you can trust.
CQI-IRCA Cretified Course
Exemplar Global Cretified Course
RAPS Cretified Course