Application of the scrum methodology in the design of medical equipment prototypes

W. Auccahuasi, Sandra Meza, Emelyn Porras, Milagros Reyes, Lucas Herrera, C. Ovalle, Hernando Martín Campos Martinez, K. Rojas, Miryam Inciso-Rojas, Aly Auccahuasi
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Abstract

In these times we are living, which has been affected mainly by the pandemic of Covid-19, in this sense many national and private institutions, from different business areas, are starting business models related to the manufacture of medical equipment, in this sense, in this paper, we indicate a method to develop medical equipment, under the SCRUM methodology, to leverage resources and improve project management, the methodology develops six major groups of activities known as Sprint, the first related to the analysis of requirements, the second with the analysis of the regulations to be met, the third related to the design of the prototype consisting of hardware and software components, the fourth related to quality testing by measuring the patterns, the fifth related to testing on patients and the sixth with the evaluation with an entity that qualifies and issues the final authorization of use, we explain the methodology in general so that it can be applied and scaled to different types of equipment.
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scrum方法在医疗设备原型设计中的应用
在我们所处的时代,主要受到Covid-19大流行的影响,从这个意义上说,许多来自不同业务领域的国家和私营机构正在启动与医疗设备制造相关的商业模式,从这个意义上说,在本文中,我们指出了一种开发医疗设备的方法,在SCRUM方法下,利用资源和改进项目管理,该方法开发了六个主要的活动组,称为Sprint,第一个与需求分析有关,第二个与要满足的法规分析有关,第三个与由硬件和软件组件组成的原型设计有关,第四个与通过测量模式进行质量测试有关,第五个与患者测试有关,第六个与合格的实体进行评估并发布最终使用授权。我们解释了一般的方法,以便它可以应用和扩展到不同类型的设备。
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