IVDR Conformity Assessment Procedures (CB001)
390 €
Learn how IVD devices are classified under the IVDR and how to select the appropriate conformity assessment procedure!
Classification • Conformity Assessment • CE Marking
Selecting the correct conformity assessment procedure under the IVDR begins with the proper classification of the device. The applicable conformity assessment route, the involvement of a Notified Body, and the required technical documentation all depend on the device’s risk class.
This e-learning course explains the relationship between Decision 768/2008/EC and the IVDR, the IVDR classification rules, and the conformity assessment procedures applicable to different risk classes. It also covers quality management system-based conformity assessment, technical documentation assessment, and type examination procedures.
Information
The course material is available anytime and anywhere through an interactive e-learning platform, allowing you to learn entirely at your own pace.
Your knowledge will be assessed through online quizzes, and upon successful completion, you will receive a certificate confirming the completion of the course and your results.
✓ Author: Attila Juhász (SAASCO Medical)
✓ Access to the course material for 6 months from the date of purchase
✓ 35-page educational material covering IVDR conformity assessment procedures
✓ Practical guidance on classification and conformity assessment routes
✓ Online quizzes to reinforce learning
✓ Glossary of key regulatory terminology
✓ Certificate of completion with assessment results
Do you have questions about the course content? Simply send us an email at info@noboversum.hu and we will forward your question to the expert for a professional response.
Topics
IVDR Conformity Assessment Procedures
- Relationship between Decision 768/2008/EC and the IVDR
- Classification rules for IVD medical devices
- Conformity assessment procedures by risk class
- Quality management system-based conformity assessment
- Technical documentation assessment
- Type examination procedures
