医疗器械设计开发合规性所涉及的DHF/DMR/DHR
DHF – Design History File
The DHF is the design history file.
DHF是设计历史文档。
duplicate part reference
As you go through the design anddevelopment process foryour medical device, the documentation that you createis going to be containedhere.
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, thedesignhistory file shall contain or reference the records necessary todemonstratethat the design was developed in accordance with the approved designplan andthe requirements of this part (21CFRPart 820.30). Each
manufacturer shall establish and maintain aDHFfor 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 fairlystraightforward. Inpractice, that can be a bit of a challenge if you don’t compileit 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 referenceto all of therecords related to the activities you did during the design anddevelopmentprocess.
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 needsand designinputs 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 yougenerated to build thedevice. 为制成器械而生成的所有设计输出。
All of the designverificationand 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 alongwith all ofthat…and don’t forget everything for transferring the device tomanufacturingtoo.
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 documentscompiled intoyour 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 andtest the deviceis contained here.
它包含了制造和测试器械所需的一切。
According to the FDA, the DMR foreachtype of device shall include, or refer to the location of, thefollowinginformation: 根据FDA的规定，每种医疗器械的DMR应包括或提及以下信息的位置：
(a)    Device specificationsincluding appropriate drawings, composition,formulation, componentspecifications, and software specifications;
器械规格，包括适当的图纸，成分，配方，组件规格和软件规格;
(b)    Production processspecifications including the appropriate equipmentspecifications, productionmethods, production procedures, and productionenvironment specifications;
生产工艺规范，包括适当的设备规格，生产方法，生产程序和生产环境标准;
(c)    Quality assuranceprocedures and specifications including acceptancecriteria and the qualityassurance equipment to be used;
质量保证程序和规范，包括验收标准和使用的质量保证设备;
(d)    Packaging and labelingspecifications, including methods and processesused; and
包装和标签规格，包括采用的方法和工艺;
(e)    Installation,maintenance, and servicing procedures and methods.
安装，维护和维修程序和方法。
Each manufacturer shall ensure thateachDMR is prepared and approved in accordance with 21CFRPart 820.40.
每个制造商应确保每个DMR按照21 CFR Part 820.40进行准备和批准。
Some parts of this should sound a lot likewhat you justgot done compiling in the DHF.
这里的部分内容很像刚刚提到的DHF的编写。

版权声明：本站内容均来自互联网，仅供演示用，请勿用于商业和其他非法用途。如果侵犯了您的权益请与我们联系QQ:729038198，我们将在24小时内删除。