Comply Guru Worldwide Sites
Home Training Courses ISO 13485 + EU MDR Internal Auditor Training

ISO 13485 + EU MDR Internal Auditor Training

97% Recommended
CQI-IRCA Cretified Course

ISO 13485 + MDR Internal Auditor Training is for anyone that wants to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485, including the additional requirements under EU MDR 2017/745, in accordance with ISO 19011.

Our blended learning course is a hybrid approach where you first complete eLearning modules on the underlying theory that better prepares you in advance of attending Live Classes with an Instructor that focus on practical application in a real life context.

An application has been made to CQI & IRCA for this course to be able to offer global recognition for successful participants.

ISO 13485 + EU MDR Internal Auditor Training
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
 
Course Snapshot
Approved By
CQI & IRCA Application Made
Duration
24hrs
Teaching Format
Blended 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.
Sample Certificate of ISO 13485 + EU MDR Internal Auditor Training

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.

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

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

Zoran Klaric

Manager Regional Training & Onboarding

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

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

Mario Arbesu

VP of Quality Assurance & Regulatory Affairs

How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

FEATURED CUSTOMER

How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

“Comply Guru took the stress out of training. Their courses didn’t just tick a box—they added real value to our quality system.”
Bernard Wallace

Bernard Wallace

Quality Affairs Manager

Our Methodology

Blended Learning is Better Learning

A two-step methodology with eLearning modules that help you master the theory better preparing you for practical workshops that embed the skills.

Blended Learning is Better Learning
Blended Learning is Better Learning
 

Course Structure Explained

Detailed Breakdown & Agenda

Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.

Time Topic
Module 1

Module 1: Overview of ISO 13485 

  • Introduction to ISO 13485
  • Terms and Definitions
  • Plan Do Check Act
  • Documentation Requirements
  • Process Based QMS
  • Risk Based Thinking
  • Management Commitment
  • Related Standards
Module 2

Module 2: Introduction to Auditing 

  • Management System Audits
  • Audit Terminology
  • Principles of Auditing
  • Audit Program Management
  • Audit Lifecycle
Module 3

Module 3: Audit Initiation and Preparation

  • Audit Planning
  • Audit Objective, Scope and Criteria
  • Selection of Audit Team and Leader
  • Audit Initiation
  • Audit Checklist Tools
  • Document Review
  • Audit Preparation Activities
  • Internal Audit Plan
  • Audit Checklist
Module 4

Module 4: Conducting Audit Activities

  • Opening Meeting
  • Communication during the Audit
  • Collecting & Verifying Information
  • Audit Findings
  • Non-Conformity Grading
  • Document Review
Module 5

Module 5: Audit Report, Close and Follow Up

  • Non-Conformity Reporting
  • Closing Meeting
  • Audit Report
  • Audit Follow Up Activities
Time Topic
09:00 - 10:00am

Course Introduction
Practical Workshop Documentation Review – Audit Plan
10:00 - 10:05am

Break
10:05 - 11:05am

Practical Workshop Audit Checklist
11:05 - 11:15am

Break
11:15am - 12:15pm

Practical Workshop Opening Meeting
Practical Workshop Simulated Case Study
12:15 - 12:20pm

Break
12:20 -1:00pm

Practical Workshop Generating Audit Findings
1:00 - 1:45pm

Lunch
1:45 – 2:45pm

Practical Workshop Generating Audit Findings (Continued)
2:45 - 2.50pm

Break
2:50 – 3:50pm

Practical Workshop Closing Meeting, Audit Report & Follow-Up
3:50 - 4:00pm

Break
4:00 - 5.00pm
  • Q&A
  • Course Wrap-Up
Time Topic
09:00 - 10:00am

Additional MDR Requirements

Key MDR Requirements not covered in ISO 13485:2016
10:00 - 10:10am

Break
10:10am - 11:10am

Audit Preparation – Document Review

How to review documents in advance of an MDR Internal Audit
11:10am - 11:20am

Break
11.20am - 12.20pm

Audit Preparation – Plan & Checklist

Developing an MDR-focused audit plan and audit checklist
12:20pm - 1:00pm

Break
1.00pm - 2.00pm

MDR Based Audit Scenarios

Scenario-based activity to analyze audit situations and identify MDR related nonconformities
2.00pm - 2.10pm

Break
2.10pm - 3.00pm

Audit Findings & Report Writing

Writing clear audit findings linked to MDR clauses
3.00pm - 3.10pm

Break
3.10pm - 4.10pm

Follow-up Activities

How to manage corrective actions, assess effectiveness, and consider regulatory implications
4.10pm - 4.20pm

Break
4.20pm - 5.30pm

Scenario Based Exercise – Audit Findings & Report

Participants develop audit findings and a short report based on an MDR Case Study

Q&A & Close out

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.

Michelle Keane

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.
Tess Egan

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

ISO 13485 + EU MDR Internal Auditor Training

Key Benefits of Choosing Comply Guru Covered
More Flexibility, More Effective & More Savings vs Other Providers
Industry-Leading Blended Learning Methodology
eLearning that Better Prepares You
Live Learning from Anywhere
Practical Workshops led by Experienced Lead Auditors
Learning Objectives Covered

With reference to the PDCA cycle, explain the process-based quality management system model for ISO 13485 and the role of an internal audit in the maintenance and improvement of quality management systems

Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up an internal quality management system audit, in accordance with ISO 19011.

Plan, conduct, report, and follow-up an internal audit of part of a quality management system based on ISO 13485, including EU MDR 2017/745, and in accordance with ISO 19011.

Course Certification

CQI IRCA

An application has been made to CQI & IRCA for course certification. Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.

What Are The Entry Requirements

Before completing this course, each Learner should have the following prior knowledge:

  • An understanding of the requirements of ISO 13485 and the commonly used quality management terms and definitions, which may be gained by completing Comply Guru’s ISO 13485 Requirements (Foundation) Training, or equivalent.
  • An understanding of the requirements of EU MDR 2017/745, which may be gained by completing Comply Guru’s EU MDR 2017/745 Practitioner Training, or equivalent
  • The Plan, Do Check, Act (PDCA) Cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
  • The fundamental concepts and the seven quality management principles (see ISO 9000).
  • The relationship between quality management, regulatory authority, and customer requirements.
  • The ISO 19011 audit process.
  • Regulatory authority requirements not directly covered in ISO 13485.

Fluency in written and spoken English

  • For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.

Copy of ISO 13485 (International Standard) and EU MDR 2017/745

  • It is recommended that each Learner should have a copy of ISO 13485:2016 (International Standard) and EU MDR 2017/745 (Regulation) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.
How Will You Be Assessed

In order 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 (applies to blended format only)
  • Fully attend the Instructor Workshops as 100% attendance is required
  • Obtain 70% or higher in the graded assessments during the Instructor Workshops
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 Internal Auditor Training

Learn about how our IRCA Approved MD-QMS Internal Auditor Training is leading the industry for innovation & learning effectiveness

 
Why Choose Blended Learning

Frequently Asked Questions

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.
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.
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.
For the live workshops, we use Zoom and Microsoft Teams. Full details will be shared with Learners upon registering for the training. 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.  
Each Learner is entitled to resit the examination once if unsuccessful in their first attempt. There is a small fee applicable for resit examinations. If unsuccessful after a 2nd attempt, you will need to re-register for the full program.
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.
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.
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.
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.

Related Training Courses

EU MDR Training for Practitioners working with the European Medical Device Regulation (2017/745)

EU MDR Requirements Training

24 hours
ISO 13485 Requirements for Practitioners and Auditors

ISO 13485 Requirements Training

10 hours
ISO 13485 Lead Auditor Training for Medical Device Quality Management Systems (MD-QMS)

ISO 13485 Lead Auditor Training

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