EU MDR Internal Auditor Training
What you'll gain from this course
Learn how to prepare for the changes from the MDD to the MDR, including audit program management and how to prepare internal audit plans and address gaps during the audit. This course also focuses on ISO 13485:2016 relative to the EU MDR and how companies can be prepared.
This instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the European Medical Device Regulation (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, EU MDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.
Tutor
This training will be delivered by one of our experts – click here to learn more .
Learning Outcomes
On completion of this EU MDR internal auditor course, you 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 to determine compliance
- Recognize the primary elements of the European Medical Devices Regulation 2017/745 (EU MDR)
- Recognize specific requirements relative to manufacturer obligations
- Identify one strategy for conducting an internal audit against the EU MDR
- Plan a manufacturer audit against the EU MDR
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