12 October 08:00 - 13 October 17:00
The course for those who plan, administer, implement or assess clinical evaluations of medtech products.
Content:
- The regulatory framework for medical devices
- Standards and European guidelines
- Clinical evaluation - verification of safety and performance by Clinical Data
- Clinical evaluation - methodological aspects
- The regulatory framework for clinical evaluation and clinical trials of medical devices
- Statistics
- Risk management - to analyze , evaluate andy control risks
- ISO 14155 - GCP for Medical Devices >
- The report of the clinical evaluation
The course will be held in Gothenburg.
Registrering