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Preclinical usability testing of the prototype

Type of study Bachelor
Language of instruction Czech
Code 660-2015/01
Abbreviation PTPP
Course title Preclinical usability testing of the prototype
Credits 4
Coordinating department Centre for Advanced Innovation Technologies
Course coordinator Ing. Lukáš Peter, Ph.D.

Subject syllabus

1. Introduction to usability testing, definition of usability testing
2. The importance of usability testing in the development of medical devices
3. Overview of the usability testing process
4. Regulatory requirements for usability testing in the development of medical devices
5. User needs and requirements, understanding user needs and requirements
6. Methods of gathering user feedback and input, incorporating user needs into device design and development
7. Usability testing methods, data collection methods (e.g. observation, surveys, interviews)
8. Types of usability testing (e.g. formative, summative, heuristic evaluation)
9. Usability testing protocols and procedures
10. Performing usability testing, preparing for usability testing
11. Testing on simulated users or in real-world environments, usability testing with special populations, performing usability testing with elderly or disabled individuals, considerations for pediatric usability testing
12. Identifying and solving potential usability problems, analyzing and interpreting data
13. New trends and technologies in usability testing
14. Usability testing as part of technical documentation, potential impact of new developments on the development of medical devices and usability testing

Literature

IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
PE, M. E. W., Kendler, J., & Strochlic, A. Y. (2015). Usability testing of medical devices. CRC press.

Advised literature

1. IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
2. Wiklund, M. E. (Ed.). (1995). Medical device and equipment design: Usability engineering and ergonomics. CRC Press.
3. 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