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Management of clinical evaluation with respect to the technology of production of medical devices

Type of study Bachelor
Language of instruction Czech
Code 660-2011/01
Abbreviation ŘKHZP
Course title Management of clinical evaluation with respect to the technology of production of medical devices
Credits 4
Coordinating department Centre for Advanced Innovation Technologies
Course coordinator Ing. Mgr. Kamila Walková, MBA

Subject syllabus

1. Legislative introduction, the relationship of clinical evaluation to production technology and materials used
2. Clinical evaluation process in general
3. Clinical trials
4. Clinical trial report
5. Post-market clinical surveillance process (PMCF)
6. Possibilities of collecting clinical data after the product is placed on the market
7. Report from the PMCF
8. Optimization of clinical evaluation with regard to the materials used - inactive medical devices
9. Optimization of clinical evaluation with regard to the materials used - active medical devices
10. Evaluation of production technologies in the process of clinical evaluation - 3D printing
11. Evaluation of production technologies in the process of clinical evaluation - standard industrial technologies
12. Use of prototypes in clinical trials - inactive medical devices
13. Use of prototypes in clinical trials - active medical devices
14. Presentation of semester projects

Literature

1. ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
2. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Presentation from lectures

Advised literature

MDCG documents
IMDRF documents