EU MDR Internal Auditor

Virtual Learning

November 30 – December 1, 2021

Course Overview

This virtual instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the upcoming European Medical Device Regulations (EU MDR). The course describes the regulation in depth from the auditor’s perspective and provides practical instruction for planning and conducting audits.
This course includes a two-hour eLearning prerequisite module titled, “EU MDR – A Comprehensive Overview” to be completed prior to the start of the live instruction. Students should have some internal audit experience, and ideally have certified auditor / lead auditor qualifications in QMS audits.

Learning Objective

At the end of this course, students will be able to:

• Plan and conduct internal and supplier audits against the
requirements of the EU MDR 2017-745

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

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

• Select appropriate samples of audit evidence necessary to
determine compliance