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The HL7 RIM in the Design and Implementation of an Information System for Clinical Investigations on Medical Devices

机译:HL7 RIM在医疗器械临床研究信息系统的设计和实现中

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The paper describes MEDIS (Medical Device Information System), a system developed to support the whole lifecycle of a Clinical Investigation (CI) for Medical Devices, providing details on the approach used in its development. MEDIS is a software system that collects and manages data and documents, exchanged between an applicant and the Italian National Competent Authority during all the phases of the business process, from the CI notification up to the submission of the final results. The development of the MEDIS Domain Analysis Model (DAM) following the HL7 v.3 methodology as well as the approach followed in the system implementation are discussed in relation to the business domain peculiarities.
机译:本文介绍了MEDIS(医疗设备信息系统),该系统是为支持医疗设备临床调查(CI)的整个生命周期而开发的,并提供了有关其开发方法的详细信息。 MEDIS是一个软件系统,用于收集和管理数据和文档,在业务流程的所有阶段(从CI通知到最终结果提交),在申请人和意大利国家主管部门之间交换。讨论了有关HL7 v.3方法的MEDIS域分析模型(DAM)的开发以及系统实现中遵循的方法,并涉及到了业务域的特殊性。

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