Specialisation
Build Expertise Beyond Drug Trials
Understand how medical-device clinical investigations and IVD performance studies differ from conventional drug trials — from evidence strategy and device deficiencies to specimen handling and performance endpoints.
Medical-device focus
- Clinical investigation planning and ISO 14155 principles
- Device description, intended purpose and risk context
- CIP, endpoints and investigation procedures
- Device deficiencies, adverse device effects and vigilance
- Monitoring, deviations and clinical-investigation reporting
- Clinical evidence, PMCF and lifecycle thinking
IVD focus
- Performance-study design and intended-use population
- Specimen selection, handling and traceability
- Comparator or reference method planning
- Analytical and clinical performance concepts
- Bias, invalid results and discrepancy management
- Performance evidence and reporting
Portfolio output
A medical-device clinical-investigation outline and an IVD performance-study evidence map.
Ready to explore Medical Device & IVD training?
Apply for the Advanced Diploma or start with the free career course to see where you fit.
Apply for Admission