Clinical Usability Studies – Clash of Cultures? Study Design Proposal from Lessons Learned

Author:

Stüdeli Thomas,Hochberg Limor

Publisher

Springer International Publishing

Reference6 articles.

1. International Electrotechnical Commission: 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices. IEC/ISO Standard No. 62366-1:AMD2020 (2020)

2. International Electrotechnical Commission: 62366-2 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices. IEC/ISO Technical Report No. 62366-2 (2016)

3. U.S. Department of Health and Human Services, Food and Drug Administration: Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff, February 3, 2016 (supersedes “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management” issued July 18, 2000)

4. Antman, E.M., Bierer, B.E.: Standards for clinical research: keeping pace with the technology of the future. Circulation 133(9), 823–825 (2016)

5. Stone, A.A., Saul Shiffman, S., Schwartz, J.E., Broderick, J.E., Hufford, M.R.: Patient compliance with paper and electronic diaries. Control. Clin. Trials 24(2003), 182–199 (2003)

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