EU IVDR Internal Auditor

Virtual Learning

September 8 – 9, 2021

Course Overview

This virtual instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the upcoming European In vitro Diagnostic Regulations (EU IVDR). The course describes the regulation for auditors and provides practical instruction for planning and conducting audits based on our EU IVDR Audit Model.

This course includes a two-hour eLearning prerequisite titled, “EU IVDR – A Comprehensive Overview” to be completed prior to the start of the live instruction. Students should have some internal audit experience, and ideally have lead auditor qualifications in QMS audits.

Learning Objective

At the end of his course, students will be able to

· Plan and conduct internal and supplier audits against the requirements of the EU IVDR 2017-745

· Identify conformity and non-conformity against the specific articles and annexes of the regulation

· Describe correspondence between the EU IVDR, ISO13485:2016 and a typical medical device manufacturer’s QMS

· Select appropriate samples of audit evidence necessary to determine compliance