TRAINING
Clinical Evidence for the IVDR
There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more recourses to maintain as well as implement.
The aim of the course is to understand clinical evidence requirements for the IVDR. Clinical Evidence including the intended purpose, Scientific Validity and literature searches, Analytical Performance requirements and Clinical Performance requirements.
Program overview
Duration: 2 hours (virtual or customized in-house, to be determined
in consultation)
- Clinical Evidence
- Format Literature Reviews to Support Scientific Validity
- Analytical Performance
- Clinical Performance
- Studies Requirements
- Performance Evaluation
- Final remarks
Who should attend?
- Regulatory Affairs Managers, Quality Managers and/or Directors
- Clinical Affairs
- R&D, Product Development
There is no prerequisite level for this course.
Costs
- Price on application for customized trainings, tailored workshops, on-location training, train-the-trainer formats or multiple training courses
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.