The training outlines the essentials of the Regulations
- The MDR and IVDR
- Explanation of terms and definitions
- Essential requirements
- Relation to risk management
- Conformity assessment procedures: regulatory pathways to market
- Clinical evaluation : what ?
In addition, essential elements of applicable IVDD-related ISO standards are addressed:
- Clinical evaluation: how ?
- classification of IVD-medical devices – focus on self testing devices
- sampling procedures and performance testing
- the clinical laboratory environment for IVD-device testing
- traceability and validation of quality control tests
- stability of reagents
- labeling requirements