660-2011/01 – Management of clinical evaluation with respect to the technology of production of medical devices (ŘKHZP)
| Gurantor department | Centre for Advanced Innovation Technologies | Credits | 4 |
| Subject guarantor | Ing. Mgr. Kamila Wálková, MBA | Subject version guarantor | Ing. Mgr. Kamila Wálková, MBA |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 2 | Semester | winter |
| | Study language | Czech |
| Year of introduction | 2024/2025 | Year of cancellation | |
| Intended for the faculties | FMT | Intended for study types | Bachelor |
Subject aims expressed by acquired skills and competences
The aim of the course is to familiarize students with the requirements for conducting clinical trials and evaluation of medical devices, especially from the point of view of the possibilities and requirements for the production technologies and materials used.
Teaching methods
Lectures
Tutorials
Summary
The student will become familiar with general information and definitions according to regulations, recommending documents and international standards in the field of regulatory requirements for the production of medical devices. Great emphasis will be placed on the ability to optimize the clinical evaluation process due to the possibilities of the technologies used for the production of MD prototypes. In the production of MD prototypes, new technologies are often used, especially 3D printing, which provides a cheap and fast tool for the realization of prototype solutions. It is possible to use these technologies with advantage, however, it is necessary to correctly set the processes that are connected with the technology itself and have an influence on the course of the aluminum test or clinical evaluation.
Compulsory 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
Recommended literature:
MDCG documents
IMDRF documents
Way of continuous check of knowledge in the course of semester
Elaboration of an individual project
Oral exam
E-learning
Other requirements
No further student requirements are required
Prerequisities
Subject has no prerequisities.
Co-requisities
Subject has no co-requisities.
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
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction
Předmět neobsahuje žádné hodnocení.