EU MDR 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 Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.

Our industry-leading blended methodology requires Learners to first complete interactive eLearning modules on the underlying theory that better prepares them before attending Live Classes with an Instructor that focus on practical application in a real life context.

Why Choose Comply Guru?
 
Comply Guru
Globally Recognized Qualification
Industry-Leading Blended Methodology
Learn from Anywhere
Live Workshops led by Experienced Lead Auditors
More Flexibility & Less Downtime at Work
Better Prepared In Advance of Live Workshops
Course Snapshot
Accreditation
CQI & IRCA No. 2696
Duration
24hrs
Available Format
Blended, Virtual or In-Person Learning
Price
GBP £  1195.00
Upcoming Dates
8th - 9th May 2024 9:00 AM - 5:00 PM BST
10th - 11th Jun 2024 9:00 AM - 5:00 PM BST
21st - 22nd Aug 2024 9:00 AM - 5:00 PM BST
Why Choose Comply Guru?
 
Comply Guru
Globally Recognized Qualification
Industry-Leading Blended Methodology
Learn from Anywhere
Live Workshops led by Experienced Lead Auditors
More Flexibility & Less Downtime at Work
Better Prepared In Advance of Live Workshops

Our Methodology

How Blended Learning Works

Blended learning is a two-step approach: Beginning with eLearning modules to grasp the foundational theory, then attending live, instructor-led classes emphasizing practical, real-world application.

How Blended Learning Works
How Blended Learning Works

Upcoming Schedule

Gain an Accredited EU MDR Auditor Qualification

Advance your knowledge and enjoy more flexibility & learning effectiveness with blended learning.

Secure Payment

Workshop Dates
Daily Schedule
Course Delivery
Location
Fee
Registration
8th - 9th May 2024
9:00 AM - 5:00 PM BST
9hrs eLearning + 2-days Live Classes + Final Exam
Virtual Workshops
GBP £ 1195.00
10th - 11th Jun 2024
9:00 AM - 5:00 PM BST
8hrs eLearning + 2-days Live Classes + Final Exam
Virtual Workshops
GBP £ 1195.00
21st - 22nd Aug 2024
9:00 AM - 5:00 PM BST
8hrs eLearning + 2-days Live Classes + Final Exam
Virtual Workshops
GBP £ 1195.00

Course Overview

EU MDR Auditor Training

Learning Objectives Covered

Explain the background and purpose of a medical device quality management system (MD-QMS) in the context of EU MDR 2017/745 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 MDR 2017/745 requirements as the audit criteria.

Plan for and conduct an audit of a medical device quality management system to establish compliance with the EU MDR 2017/745 in accordance with ISO 19011/ISO 17021 as applicable and report on any nonconformities.

What This Course Covers

A summary of learning topics within this course include:

  • The Role of ISO 13485 in achieving EU MDR compliance
  • The Role of ISO 14971 in EU MDR compliance
  • Economic Operators in the EU MDR
  • The relationship between Harmonized Standards and Common Specifications
  • Competency Requirements for the Person Responsible for Regulatory Compliance (PRRC)
  • Key General Safety Performance Requirements (GSPRs)
  • Key Technical Documentation required under the EU MDR
  • Unique Device Identification (UDI) and EUDAMED
  • Importance of Post-Market Surveillance and Vigilance under the EU MDR
  • Roles of 1st, 2nd and 3rd party Notified Bodies, and Regulatory Audits in EU MDR compliance
  • Audit Process for MD-QMS Audits under ISO 13485
  • Audit Objectives, Scope and Criteria
  • Audit Team Selection
  • Audit Methods including surveillance audits, re-audits, special and unannounced audits
  • Conducting Onsite Audits
  • Audit Frequency
  • Auditing the MD-QMS against the EU-MDR 2017/745 Criteria
  • Generating Audit Findings
  • Audit Reporting
  • Corrective Action
  • Regulatory Body Reporting
Course Accreditation & Certificate

CQI IRCA

CQI & IRCA certify this course (No. 2696). 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. 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:

  • Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for.
  • 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's Blended Learning?

Learn about how our Blended Learning Methodology is leading the industry for innovation & learning effectiveness

 
Why Choose Blended Learning

Frequently Asked Questions

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.
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.
A blended learning course is a hybrid of eLearning modules and classroom modules (in-person or virtual). Each Learner is required to successfully complete interactive eLearning modules in advance of the live workshops that form the second phase of the training.
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.
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
There are recommended requirements for each Learner in wishing to complete any of our 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.
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.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020