660-2007/01 – Risk management system for medical devices (SŘRZP)
| Gurantor department | Centre for Advanced Innovation Technologies | Credits | 4 |
| Subject guarantor | Ing. Lukáš Peter, Ph.D. | Subject version guarantor | Ing. Lukáš Peter, Ph.D. |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 1 | 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 course introduces students to the basics of risk analysis necessary for risk assessment of both production processes and products. The course will discuss all aspects of risk analysis in relation to international standards and regulations to enable the student to apply the risk management process in the design, development and prototyping of medical devices in terms of the manufacturing technologies and materials used to produce medical devices.
Teaching methods
Lectures
Tutorials
Summary
In the course, students will gain a thorough understanding of the principles and concepts underlying risk management, as well as the tools and techniques used to identify and assess the risks associated with medical devices, as well as understand the regulatory environment for medical devices and the risk management requirements set out in regulations such as ISO 14971. Students will also learn how to assess and mitigate risks associated with medical devices throughout the product life cycle, including design, manufacture, distribution and use, including evaluating the effectiveness of risk management plans and identifying areas for improvement.
Compulsory literature:
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
Recommended literature:
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
Way of continuous check of knowledge in the course of semester
Credit
- Participation in exercises - 80%
- Individual project - Requirements will be specified in the introductory lesson.
Oral exa
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. 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
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction
Předmět neobsahuje žádné hodnocení.