IVDR Technical Documentation (IR002)
690 €
Learn how to build compliant and up-to-date technical documentation according to IVDR requirements!
This e-learning course will help you understand IVDR expectations and structure your technical documentation in a systematic way, with special focus on device safety, performance, and traceability.
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.
✓ Authors: Tímea Németh Markó (NoBoMed Plc.) and György Ferenc Balázs (EMKI-Cert)
✓ Access to the course material for 3 months from the date of purchase
✓ 60-page educational material introducing the principles of technical documentation
✓ Online quizzes to reinforce learning
✓ Certificate of completion with assessment results
Do you have questions about the course content?
Simply send us an email at [email protected] and we will forward your question to the expert for a professional response.
Topics
- Meaning of terms used in performance evaluation
- The performance evaluation process
- Performance Evaluation Plan (PEP)
- Clinical Performance Evaluation Plan
- Analytical Performance Evaluation Plan
- Scientific Validity
- Post-Market Performance Follow-up Plan
- The role of the Performance Evaluation Report within the evaluation process
- Content requirements
- PER sub-reports
- Scientific Validity Report
- Analytical Performance Report
- Clinical Performance Report
- Relationship between PMS and performance evaluation
- Steps of post-market performance follow-up
- Content requirements of the PMPF Plan
- Relevant Standards
