1. Introduction to the output control of medical devices - definition and meaning, regulatory requirements, international standards and regulations
2. Requirements for technical documentation of final inspection and type tests – reports, protocols, requirements for documentation and reporting.
3. Measuring and testing techniques - calibration and verification, testing methods
4. Aspects of tests for output control. Practical examples
5. Methodologies for testing the output control of used materials
6. Type test - definition and meaning, regulatory requirements, safety testing
7. Test and evaluation methods used in type examination
8. Relationship of type examination and conformity assessment procedure - Module B: EC type examination, Module C: Conformity to type
9. Methods of testing and evaluating mechanical safety during final inspection
10. Verification of traceability – identification and marking of medical devices
11. Requirements for testing as part of regular safety inspections
12. New technologies and trends for retesting of output control/PBTK
2. Requirements for technical documentation of final inspection and type tests – reports, protocols, requirements for documentation and reporting.
3. Measuring and testing techniques - calibration and verification, testing methods
4. Aspects of tests for output control. Practical examples
5. Methodologies for testing the output control of used materials
6. Type test - definition and meaning, regulatory requirements, safety testing
7. Test and evaluation methods used in type examination
8. Relationship of type examination and conformity assessment procedure - Module B: EC type examination, Module C: Conformity to type
9. Methods of testing and evaluating mechanical safety during final inspection
10. Verification of traceability – identification and marking of medical devices
11. Requirements for testing as part of regular safety inspections
12. New technologies and trends for retesting of output control/PBTK