FDA 510(K)软件评审要求文档.pptVIP

5. Architecture Design Chart设计模块架构图 This document is typically a flowchart or similar depiction of the relationships among the major functional units in the Software Device, including relationships to hardware and to data flows such as networking. 文件典型的是流程图或类似软件器械主要功能个体的描述，包括与硬件的联系和网络数据流程。 6. Software Design Specification软件设计规格书 The Software Design Specification (SDS) describes the implementation of the requirements for the Software Device. In terms of the relationship between the SRS and the SDS, the SRS describes what the Software Device will do and the SDS describes how the requirements in the SRS are implemented. 软件器械规格（SDS）描述软件器械要求的执行。根据SRS和SDS的关系，SRS描述软件器械要做什么和SDS描述SRS中执行的要求。 7. Traceability Analysis 可追溯性分析 A Traceability Analysis links together your product design requirements, design specifications, and testing requirements. It also provides a means of tying together identified hazards with the implementation and testing of the mitigations. 一个可追溯性分析与产品的设计要求、设计规格、测试要求是联系在一起的。它同时给出把识别危害、缓解测试和执行联系在一起的方法。 8. Software Development Environment Description软件开发环境的描述 For Moderate and Major Level of Concern Software Devices, the submission should include a summary of the software development life cycle plan. This summary should describe the sponsor’s software development life cycle and the processes that are in place to manage the various life cycle activities. For Major Level of Concern Software Devices, this document should also include an annotated list of the control/baseline documents generated during the software development process and a list or description of software coding standards. 对于中等和严重关注的软件器械，提交文件中应包括软件开发生命周期规划的概要。该概要应描述提交者的软件开发生命周期和在适当位置管理各种各样的生命周期活动的过程。对严重关注的器械软件，该文件应也涵盖在软件开发过程和软件译码标准的清单或描述中控制／基线文件的注解单。 9. Verification and Validation Documentation验证和确认文件 For Minor Level of Concern devices, we recommend that you submit documentation of system or device level testing, and, where appropriate, integration testing. The documentation submitte