TY - GEN
T1 - A Critical Review on Hazard Analysis and Risk Assessment for Development of Wearable Medical Devices
AU - Chak, W. Y.
AU - Tang, W. F.
AU - Mak, S. L.
AU - Lee, C. C.
AU - Lam, S. K.
AU - Li, C. H.
N1 - Publisher Copyright:
© 2023 IEEE.
PY - 2023
Y1 - 2023
N2 - Many patients suffer from variable chronic illness. In the past, the patients are required to carry out health check in half year or yearly interval. However, the result is only to reflect the instantaneous health index, for example the glucose level in blood. The wearable medical device is a good solution to the medical doctors to understand the patient's continuous health status. This paper aims to review the different hazard analysis and risk assessment approaches for developing the wearable medical devices. In the beginning, the need for wearable medical devices is discussed, Secondly, the typical product development cycle is reviewed, Thirdly, different hazard analysis and risk assessment approaches are reviewed and summarized. Finally, a conclusion is made to recommend to the developers.
AB - Many patients suffer from variable chronic illness. In the past, the patients are required to carry out health check in half year or yearly interval. However, the result is only to reflect the instantaneous health index, for example the glucose level in blood. The wearable medical device is a good solution to the medical doctors to understand the patient's continuous health status. This paper aims to review the different hazard analysis and risk assessment approaches for developing the wearable medical devices. In the beginning, the need for wearable medical devices is discussed, Secondly, the typical product development cycle is reviewed, Thirdly, different hazard analysis and risk assessment approaches are reviewed and summarized. Finally, a conclusion is made to recommend to the developers.
KW - Hazard Analysis
KW - Risk Assessment
KW - Wearable Medical Devices
UR - http://www.scopus.com/inward/record.url?scp=85182932443&partnerID=8YFLogxK
U2 - 10.1109/ISPCE-ASIA60405.2023.10365802
DO - 10.1109/ISPCE-ASIA60405.2023.10365802
M3 - Conference contribution
AN - SCOPUS:85182932443
T3 - ISPCE-AS 2023 - IEEE International Symposium on Product Compliance Engineering - Asia 2023
BT - ISPCE-AS 2023 - IEEE International Symposium on Product Compliance Engineering - Asia 2023
T2 - 2023 IEEE International Symposium on Product Compliance Engineering - Asia 2023, ISPCE-AS 2023
Y2 - 3 November 2023 through 5 November 2023
ER -