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首页> 外文会议>18th Annual International Symposium of the International Council on Systems Engineering(INCOSE 2008) >Medical Device Development Process
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Medical Device Development Process

机译：医疗器械开发流程

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Medical devices of increasing complexity are central to mankind's continuously expanding ability to save lives and improve the quality of life. Within our business, we often reflect on how fortunate we are to have the opportunity to work on a variety of these remarkable devices. We believe that such rewarding experiences are made possible through the application of a rigorous system engineering process, ensuring that the resulting devices are safe, effective, and successful.rnThis paper describes a deployed System Engineering process tailored for Medical Device Development. This process (based on ISO 15288:2002, the INCOSE System Engineering Handbook and a Legacy Process) , integrates compliance to international regulations, embeds a Safety Risk Management process as defined in ISO 14971:2007, and assures adherence to ISO 13485:2003 Quality management systems. Based on the classification and complexity of the device the process is scalable, may be tailored, and supports iterative design and development activities.
机译：日益复杂的医疗设备对于人类不断扩大的挽救生命和改善生活质量的能力至关重要。在我们的业务中，我们经常思考有机会在各种出色的设备上工作是多么幸运。我们相信，通过应用严格的系统工程流程可以确保获得如此丰厚的体验，从而确保所产生的设备安全，有效和成功。本文描述了为医疗设备开发量身定制的已部署系统工程流程。此过程（基于ISO 15288：2002，《 INCOSE系统工程手册》和旧版过程），整合了对国际法规的遵从性，嵌入了ISO 14971：2007中定义的安全风险管理过程，并确保遵守ISO 13485：2003质量管理系统。基于设备的分类和复杂性，该过程是可扩展的，可以定制的并支持迭代设计和开发活动。

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