February 20 – 21, 2024
This instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU MDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU MDR.
This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union Medical Device Regulation (EU MDR). The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning, and conducting EU MDR audits according to NSF’s formal, documented EU MDR Audit Model.
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 pre- and post-market requirements associated with EU MDR – standard regulatory requirements that must be met by all medical device manufacturers wishing to do business in the EU regardless of device classification.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
Who should attend:
This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU MDR, for managers of audit programs, and for anyone who will be the subject or participate in an EU MDR audit. Learners should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.
ISO 13485:2016 Overview and Country-Specific Medical Devices Regulations: Six-Course Bundle
Post-Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
Deviation Investigations and CAPA