Preclinical usability testing of the prototype

Preclinical usability testing of the prototype
660-2015/01
čeština

Summary

The aim of preclinical testing of the usability of medical devices is to evaluate the safety, effectiveness, and user-friendliness of the device before it is approved for use in humans. This type of testing is typically conducted on animals or in simulated laboratory conditions, and it involves testing the device's design, functionality, and ease of use by users with varying levels of experience. By conducting preclinical testing of the usability of medical devices, researchers can help ensure that these devices are safe, effective, and user-friendly when they are ultimately approved for use in clinical trials and medical practice. This can help to minimize the risk of harm to patients and improve the overall quality of care in the healthcare industry.

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

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Language of instruction	čeština
Code	660-2015
Abbreviation	PTPP
Course title	Preclinical usability testing of the prototype
Coordinating department	Centre for Advanced Innovation Technologies
Course coordinator	Ing. Lukáš Peter, Ph.D.