MD Soft

Quality-by-Design of Software for Medical Devices


Any software devoted to medical devices or in vitro diagnostic has to be conformed with the ISO 62304. The risks and performances associated with the software outcomes has to be fully controlled. Unfortunately the number of internal parameters to be tuned can drop drastically and at the same time the number of trials and therefore the time of development.

We present thereafter how the Quality-by-Design approach has been applied to the optimal tuning of a software devoted to the detection of a pathology. Two requirements of sensitivity and specificity are specified. At the end, two tuning parameters have been investigated to find the region in which the targeted objectives can be reached.































T​his type of study allows to quickly find the parameter settings leading to the optimal performances.


[1] P. Guyot, E.-H. Djermoune, T. Bastogne, and B. Chenuel, “A single ECG lead-based oscillation index for the quantification of periodic breathing in severe heart failure patients,” in 27th European Signal Processing Conference, EUSIPCO 2019, (Coruna, Spain), Sept. 2019.

[2] P. Guyot, E.-H. Djermoune, B. Chenuel, and T. Bastogne, “Estimation d’un indice d’oscillation à partir d’un signal ECG pour la quantification de la respiration périodique chez des patients insuffisants cardiaques sévères,” in XXVIIème Colloque francophone de traitement du signal et des images, GRETSI 2019, (Lille, France), Aug. 2019.

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