Course description
European Medical Device Regulation (EU MDR) Internal Auditor
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 auditors 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.
Suitability - Who should attend?
This course is helpful for experienced internal auditors seeking to expand their auditing knowledge to the EU MDR. Students should have some internal audit experience, and ideally have certified auditor/lead auditor qualifications in QMS audits.
Training Course Content
- 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 manufacturers QMS
- Select appropriate samples of audit evidence necessary to determine compliance
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 5
Robert Ruff is such a great teacher. He consistently asked for feedback and encouraged engagement. He was also very considerate of the multi-time zones we were working in.
The instructor was awesome and knowledgeable - had a great way of explaining the MDR, with an emphasis on what we as auditors should be looking for as we audit our systems and p...
The training material and content was applicable for me and I will be able to use the information and training material in a very positive way.