References
- ISO 13485: 2016. Medical devices—quality management systems—requirements for regulatory purposes. 2016.
- IEC EN 62366-1:2015. Medical devices: part 1: application of usability engineering to medical devices. 2015.
- US FDA. Guidance for industry and food and drug administration staff: applying human factors and usability engineering to medical devices. 2016.
- AAMI HE75:2009. Human factors engineering – design of medical devices. 2009.
- MDCG 2021-6 Rev. 1, Regulation (EU) 2017/745 – questions & answers regarding clinical investigation. 2023.
- IEC EN 62366-2:2015, Medical devices: part 2: guidance on the application of usability engineering to medical devices. 2015.
- US FDA. Guidance for industry and food and drug administration staff: application of human factors engineering principles for combination products: questions and answers. 2023.
- MHRA. Guidance on applying human factors and usability engineering to medical devices include drug-device combination products in Great Britain. 2021.