FDA对DHFamp;DMRamp;DHR的要求分析.pdf

DHF –Design History File The DHF is the design history file. DHF 是设计历史文档。 As you go through the design and development process for your medical device, the documentation that you create is going to be contained here. 它包含在完成医疗器械的设计和开发过程时所创建的文档。 According to the FDA, the design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan andthe requirements of this part (21CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device. 根据FDA 的规定，设计历史文件应包含或引用必要的记录，以证明设计是根据批准的设计 方案和21 CFR Part 820.30 的要求制定的。每个制造商应为每种类型的器械建立和保存DHF 文档。 The actual idea of the DHF is fairly straightforward. In practice, that can be a bit of a challenge if you don’t compile it as you go. DHF 的实际意图相当简单。如果你在实践中不去编写它，这可能是一个挑战。 You need to include or provide a reference to all of the records related to the activities you did during the design and development process. 你需要包括或提供你在设计和开发过程中所做的活动有关的所有记录。 That means you need all of the user needs and design inputs you came up with at the start of the project. 这意味着你需要在项目开始时提出的所有用户需求和设计输入。 All of the design outputs that you generated to build the device. 为制成器械而生成的所有设计输出。 All of the design verification and validation protocols and reports. 所有的设计验证和确认的方案和报告。 Plus, all of design reviews that went along with all of that…and don’t forget everything for transferring the device to manufacturing too. 此外，与此相关的所有的设计评审...不要忘记把器械转移到生产的过程。 Once you’ve gotten all of those documents compiled into your DHF, the next acronym that needs to be tackled is the DMR. 一旦将所有这些文档编写到DHF 中，需要解决的下一个首字母缩略词就是DMR 。 DMR –Device Master Record The DMR is the device master record. DMR 是器械主记录。 Everything you need to know to build and test the device is contained here. 它包含了制造和测试器械所需的一切。 According to the FDA, the DMR for each type of device shall include, or refer to the l