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EU MDR Auditor Training Course for Europe’s Medical Device Regulation (2017/745)

Designed for experienced auditors who are already familiar with ISO 13485 and
ISO 14971, this interactive, case study-based training will prepare you to conduct internal and supplier audits to EU MDR requirements using real-life scenarios and examples. Through class discussion, immersive audit exercises and case studies, real-world examples, lectures led by an expert instructor, in-class assessments, and a cumulative final exam, this training equips experienced medical device quality management system (QMS) internal and second-party auditors with the regulatory knowledge necessary to plan, and prepare to perform, audits to determine EU MDR compliance. If you are not an auditor, consider our EU MDR overview training class instead.

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Brief Overview of This EU MDR Auditing Course

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certificate of Completion

Yes

Continuing Education Units (CEUs)

2.8

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming European Medical Device Regulation Auditor Training Classes

SkillsLab $3595

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
LEF VIRTUAL DELIVERY (Eastern Time) 24 Jun 2024 28 Jun 2024 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER
LEF VIRTUAL DELIVERY (Eastern Time) 05 Aug 2024 09 Aug 2024 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER
LEF Minneapolis, MN 19 Aug 2024 22 Aug 2024 8:00AM - 5:00PM Central US Time In-Person REGISTER
LEF VIRTUAL DELIVERY (Eastern Time) 16 Sep 2024 20 Sep 2024 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER
LEF San Francisco Area, CA 21 Oct 2024 24 Oct 2024 8:00AM - 5:00PM Pacific US Time In-Person REGISTER
LEF VIRTUAL DELIVERY (Eastern Time) 28 Oct 2024 01 Nov 2024 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER
LEF VIRTUAL DELIVERY (Eastern Time) 09 Dec 2024 13 Dec 2024 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive EU MDR Auditing Class

Through class discussion, immersive auditing exercises and case studies, real-world examples, lectures led by an expert instructor, in-class assessments, and a cumulative final exam, this training equips experienced medical device quality management system (QMS) internal and second-party auditors with the regulatory knowledge necessary to plan, and prepare to perform, audits to determine EU MDR compliance.

Course Overview
SkillsLab Class

Develop an Audit Plan for an EU MDR Audit

  • Review QMS audit fundamentals and ISO 19011:2018 key concepts in the context of EU MDR audits
  • Discuss EU MDR internal audit risks

EU Medical Device Regulation Basics

  • Review the reasons driving the change from Medical Devices Directive (MDD) to MDR, and when compliance is expected
  • Assess a company’s entities, roles, and device information against major EU MDR requirements to determine compliance
  • Examine quality management system linkages to the regulation, and the relationship between EU MDR and ISO 13485
  • Discuss recent regulatory news, implementing acts, and other updates related to auditing EU MDR
Exercise! Locate Audit Criteria in the EU MDR document
Case Study! Assess Entities, Roles, and Device Information

Audit Planning Considerations

  • Review a risk-based approach to audit preparation activities: plan audit resources, develop the audit plan, create working documents
Exercise! Write an EU MDR Internal or Supplier Audit Plan

Auditing EU MDR Premarket Requirements

  • Explain how a risk-based approach to device classification is achieved so that it can be assessed
  • Verify conformity assessment routes and ensure the impact of any additional scrutiny is minimized
Exercise! Create an Audit Checklist for Device Classification
Case Study! Audit the Justification for Risk-Based Classification of a Device

Auditing EU MDR QMS Requirements

  • Identify economic operator and PRRC responsibilities, and explain how this knowledge applies to auditing against EU MDR
  • Examine the relationship between ISO 13485 and EU MDR requirements
  • Identify EU MDR audit focus areas for an ISO 13485-conforming QMS
Exercise! Identify Economic Operator Responsibilities
Exercise! Create a PRRC Audit Checklist
Exercise! Apply a Risk-Based Approach to Auditing the QMS
Exercise! QMS Audit Evidence for Article 10

Auditing EU MDR Product Realization

  • Explore ways to organize, communicate, and verify risk management related to General Safety and Performance Requirements (GSPRs) 
  • Creating a working document
  • Describe the role of common specifications
Case Study! Audit Risk Management Procedure
Case Study! General Safety and Performance Requirements (GSPRs)
Exercise! Create a Checklist for Auditing Change Controls
Exercise! Create Working Documents for Auditing Technical Documentation

Auditing EU MDR Clinical Evaluation Processes

  • Study EU MDR clinical evidence, investigation and evaluation requirements, and related auditing tips
  • Explore the role of MEDDEV 2.7/1 rev. 4 guidance in EU MDR compliance
  • Examine EU MDR postmarket clinical follow-up (PMCF) requirements
  • Audit a clinical evaluation report to determine how well it meets EU MDR requirements
Case Study! Audit Clinical Evaluation Report

Auditing EU MDR UDI, Labeling, and PMS Processes

  • Practice auditing EU MDR UDI and labeling
  • Audit EU MDR postmarket surveillance (PMS) activities
Case Study! Auditing UDI and Labeling
Case Study! Postmarket Surveillance (PMS)

Concluding the EU MDR Audit

  • Identify the post-audit tasks and audit follow-up differences in EU MDR internal audits and supplier audits
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Understand linkages and gaps between ISO 13485:2016 and EU MDR requirements.

During an audit, recognize concerns, noncompliance, acceptable evidence, and best practices in these areas: device classification, risk management and general safety and performance requirements (GSPRs), clinical evaluation, technical documentation, Unique Device Identification (UDI), labeling, and postmarket surveillance.

Assess how well an organization addresses EU MDR-specific roles such as economic operators and persons responsible for regulatory compliance (PRRC).

Identify sufficient evidence to satisfy all EU MDR Article 10 (general obligations of manufacturers). 

Write audit EU MDR checklist questions for key processes, and apply feedback from industry experts and peers. 

Develop an audit plan for an EU MDR audit.  

Who Should Attend

Who Should Attend

Designed for management system auditors performing internal or supplier audits against the EU MDR, and for individuals or teams conducting EU MDR 2017/745 gap assessments. Attendees should have experience performing process and risk-based management audits aligned with ISO 19011:2018 guidance. Knowledge of medical device quality management systems conforming to EN ISO 13485:2016 and  EN ISO 14971:2019 is also recommended. Please read the EU Medical Device Regulation 2017/745 prior to attending class.

  • Internal Auditors
  • QMS Consultants
  • Supplier Auditors
  • Gap Assessment Professionals
  • QMS Personnel

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