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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

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

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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