The safety and clinical effectiveness of medical devices are closely associated with their specific use in clinical treatments. Assuring safety and the desired clinical effectiveness is challenging. Different people may react differently to the same treatment due to variability in their physiology and genetics. Thus, we need to consider the outputs and behaviour of the device itself as well as the effect of using the device to treat a wide variety of patients. High-intensity focused ultrasound systems and radiation therapy machines are examples of systems in which this is a primary concern. Conventional monolithic assurance cases are complex, and this complexity affects our ability to address these concerns adequately. Based on the principle of separation of concerns, we propose separating the assurance of the use of these types of systems in clinical treatments into two linked assurance cases. The first assurance case demonstrates the safety of the manufacturer's device independent of the clinical treatment. The second demonstrates the safety and clinical effectiveness of the device when it is used in a specific clinical treatment. We introduce the idea of these separate assurance cases, and describe briefly how they are separated and linked.

翻译：医疗器械的安全性和临床有效性与它们在临床治疗中的具体使用密切相关。确保安全性和预期的临床有效性具有挑战性。由于患者生理和遗传的多样性，不同个体对同一治疗可能产生不同反应。因此，我们既需要考虑器械本身的输出和行为，也需要考虑使用该器械治疗不同患者产生的影响。高强度聚焦超声系统和放射治疗设备是这类问题的典型例子。传统的单一化保证案例结构复杂，这种复杂性削弱了我们充分应对这些问题的能力。基于关注点分离原则，我们提出将此类系统在临床治疗中的保证分为两个相互关联的保证案例：第一个保证案例证明制造商器械在独立于临床治疗时的安全性；第二个则证明器械在特定临床治疗中的安全性和临床有效性。本文介绍了这些独立保证案例的概念，并简要说明了它们如何分离与关联。