European Medical Device Regulation (EU MDR) Internal Auditor

Virtual Learning

October 13 – 15, 2020

Course Overview

This fully online 3-day training course is designed to provide practical instruction for auditors undertaking internal and supplier audits for the upcoming European medical device regulations (EU MDR). It is anticipated that students will already have internal audit experience and ideally have certified auditor / lead auditor qualifications in QMS audits.

The course will:

  1. Briefly describe the Regulation for the auditors
    • Ensure an understanding of the framework of the regulation in order to recall quickly
  2. Briefly provide practical instruction for Planning audits
    • Specifically addressing Design, Technical documentation, Manufacturing, Supply-chain, Economic operators, Post-market support including servicing / sales affiliates etc.
  3. Briefly provide practical instruction for Conducting audits
    • Specifically Auditing technical documentation, design process, manufacturing processes, suppliers, QMS processes

This course comes with a 2-hour "EU MDR Overview" overview prerequiste module that must be completed prior to the start of the live instruction.