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QA/RA Consulting, Auditing & Training

EU IVDR Auditor Training Class (2017/746)

The new European In Vitro Diagnostic Regulation imposes strict new QMS, performance evaluation, postmarket surveillance, and other requirements on IVD manufacturers. Since many IVD manufacturers will be experincing a European Notified Body audit for the first time in their quest for CE certification, conducting internal IVDR audits is essential. Using a case-study approach, we cover audit planning, IVDR premarket considerations, QMS requirements, performance evalaution reports, labeling, PMS, audit conduct, and more! Not an auditor? Consider our IVDR Overview class instead.

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Brief Overview of This EU IVDR Auditing Training Course

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEU)

2.8

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3.5 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 Classes on Auditing to the EU In Vitro Diagnostic Regulation (2017/746)

SkillsLab $3595

SkillsLab $3595

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

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 European IVDR Auditor Class

Through class discussions, audit exercises, case studies, and lectures led by an expert instructor, 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 IVDR compliance.

Course Overview

SkillsLab Class

Auditing Basics Applied to EU IVDR Audits

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

EU IVDR Basics

Review the reasons driving the change from In Vitro Diagnostic Devices Directive (IVDD) to IVDR, and when compliance is expected
Assess a company’s entities, roles, and device information against major EU IVDR requirements to determine compliance
Examine quality management system linkages to the regulation, and the relationship between EU IVDR and ISO 13485
Discuss recent regulatory news, implementing acts, and other updates related to auditing EU IVDR

Exercise! Locate Audit Criteria

Exercise! Assess Entities, Roles, and Product Information

EU IVDR 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 IVDR Internal or Supplier Audit Plan

Auditing EU IVDR 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 EU IVDR Device Classification Checklist

Exercise! Audit the Justification for Risk-Based Classification of a Device

Auditing EU IVDR QMS Requirements

Identify economic operator and PRRC responsibilities, and how this applies to auditing against EU IVDR
Examine the relationship between ISO 13485 and EU IVDR requirements
Identify EU IVDR audit focus areas for an ISO 13485-conforming QMS
Determine the audit evidence needed to satisfy EU IVDR Article 10 manufacturing obligations

Exercise! Economic Operator Responsibilities

Exercise! Create a PRRC Audit Checklist

Exercise! Apply a Risk-Based Approach to Auditing the QMS

Exercise! QMS Audit Evidence for EU MDR Article 10

Auditing EU IVDR Product Realization

Explore ways to organize, communicate, and verify risk management related to general safety and performance requirements (GSPR)
Practice auditing GSPR document samples and technical documentation
Write a checklist for auditing changes controls
Create a working document to audit technical documentation
Describe the role of common specifications (CS)

Exercise! Audit a Risk Management Procedure

Exercise! General Safety and Performance Requirements (GSPR)

Exercise! Create a Checklist for Auditing Change Controls

Exercise! Create Working Documents for Auditing Technical Documentation

Auditing EU IVDR Performance Evaluation Processes

Study EU IVDR performance evidence, investigation and evaluation requirements, and related auditing tips
Examine EU IVDR postmarket performance follow-up (PMPF) requirements
Audit a performance evaluation report to determine how well it meets EU IVDR requirements

Exercise! Audit a Performance Evaluation Report (PER)

Auditing EU IVDR UDI, Labeling, and PMS Processes

Audit EU IVDR postmarket surveillance (PMS) activities

Exercise! Auditing UDI and Labeling

Exercise! Postmarket Surveillance (PMS)

Concluding the EU IVDR Audit

Identify the post-audit tasks and audit follow-up differences in EU IVDR internal audits and supplier audits

What You Will Learn

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

SkillsLab

Using audit tools and a risk-based approach, note which linkages and gaps between an EN ISO 13485:2016+A11-conforming system and the EU IVDR requirements can improve your audit planning and focus your audit preparation.

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

Identify sufficient evidence to satisfy all EU IVDR Article 10 General obligations of manufacturers.

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

Develop an audit plan for an EU IVDR audit.

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

Who Should Attend

This course is designed for auditors with experience auditing to ISO 13485 but will also help auditor-facing personnel prepare for Notified Body audits.

QMS Auditors
Supplier Auditors
Internal Auditors
Gap Assessment Teams
RA Audit Managers

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