ISO 13485 + EU MDR Internal Auditor Training

97% Recommended

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

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

Individual Price

Request Quote

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

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Manager Regional Training & Onboarding

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VP of Quality Assurance & Regulatory Affairs

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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.”

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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.

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.

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

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

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

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.

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.

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.

What is blended learning?

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.

Related Training Courses

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

EU MDR Requirements for Practitioners

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ISO 13485 Lead Auditor Training

40 hours