Risk management system for medical devices
| Type of study | Bachelor |
|---|---|
| Language of instruction | Czech |
| Code | 660-2007/01 |
| Abbreviation | SŘRZP |
| Course title | Risk management system for medical devices |
| Credits | 4 |
| Coordinating department | Centre for Advanced Innovation Technologies |
| Course coordinator | Ing. Lukáš Peter, Ph.D. |
Osnova předmětu
1. Normative basis
2. Terminology
3. Risk management process
4. Risk analysis
5. Risk assessment
6. Risk reduction process
7. Risk control
8. Risk benefit analysis
9. Evaluation of the total residual risk
10. Review of risk management
11. Risk analysis of the production process
12. Risk analysis in relation to materials and production technologies
13. Production and post-production activities
14. Presentation of the semester project
2. Terminology
3. Risk management process
4. Risk analysis
5. Risk assessment
6. Risk reduction process
7. Risk control
8. Risk benefit analysis
9. Evaluation of the total residual risk
10. Review of risk management
11. Risk analysis of the production process
12. Risk analysis in relation to materials and production technologies
13. Production and post-production activities
14. Presentation of the semester project
E-learning
Povinná literatura
1. LEPAKHIN, K. V. Medical Device Regulations–Global Overview and Guiding Principles. WHO, Geneva, 2003.
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
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
Doporučená literatura
1. ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
2. ISO 14971:2019 Medical devices — Application of risk management to medical devices
Other applicable regulations and standards
2. ISO 14971:2019 Medical devices — Application of risk management to medical devices
Other applicable regulations and standards