Course description
European In Vitro Diagnostic Regulation (EU IVDR) Internal Auditor
This instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the European In Vitro Diagnostic Regulation (EU IVDR). The course describes the regulation for auditors and provides practical instruction for planning and conducting audits based on our EU IVDR audit model, which has consistently received great feedback.
Gain valuable knowledge on the changes and the key difference between IVDR and IVDD and the notified body review process for the IVDR.
This course includes a two-hour eLearning prerequisite, EU IVDR A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers all aspects of the regulation and identifies key topics and changes, including the economic operators and new roles associated with the EU IVDR, standard requirements that must be met by all IVD manufacturers, and pre- and post-market requirements of conformity assessment.
Upcoming start dates
Suitability - Who should attend?
This EU IVDR internal auditor course is helpful for experienced internal auditors seeking to expand their auditing knowledge to the EU IVDR. Students should have some internal audit experience, and ideally have lead auditor qualifications in QMS audits.
Training Course Content
At the end of this training, you will be able to:
- Plan and conduct internal and supplier audits against the requirements of the EU IVDR
- Identify key articles and annexes of the EU IVDR
- Recognize the intent of requirements as described in recitals
- Identify classification implementation and classification rules
- Identify general safety and performance requirements (GSPRs)
- Recognize content of technical documentation
- Identify post-market surveillance reporting and vigilance obligations
- Recognize one EU IVDR audit model
- Plan an EU IVDR audit
- Document nonconformities against EU IVDR requirements
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
Interactive work to get to know the standard
Tips about where in the regulation information can be found. Flow chart of classification of devices.
James was a wonderful instructor, his knowledge and understanding of IVDR is evident and he is ale to explain the regulation requirements in a very applicable manner.