没分清DHF、DMR、DHR，别说你懂医疗器械设计控制!
2024年3月22日 · dmr和dhf有什么不同？ 主要区别在于记录的对象：DMR是对器械生产、检验、追溯过程的记录，而DHF是对器械设计过程的记录。 DHF文件有时包括某些DMR文件，例：器械规范（包含于技术要求）、生产工艺规范（包含于设计转换）、包装和标签(包含于设计输出）。
医疗器械：DHF、DMR、DHR的介绍 - 知乎 - 知乎专栏
医疗器械行业经常看到dhf、dmr、dhr，初步接触时，几个缩写词容易混淆，本文看一下三者的定义及区别。 1、DHF（Design history file）设计历史文档（DHF ) 指的是描述某医疗器械成品 设计过程的有关记录。
Creating DHF (Design History File) for Medical Device Systems
2012年7月11日 · I intend to have a DHF binder for each phase with an index that includes pointers to many documents with some key phase deliverables - Project Plan, Phase Review approvals, FMEAs, Risk Management Plan and Report, Product Reqt's, and a …
Technical File vs. 510(k) vs. Design History File: What Medical …
2017年6月9日 · When you see the acronym “DHF” this is talking about the design history file, which is simply the collection of documents from the design and development process. Here’s how the FDA describe it in 21 CFR Part 820.30 (j): “Each manufacturer shall establish and maintain a DHF for each type of device.
Design Control - Medical Device Academy
2017年8月22日 · What is a DHF? DHF is an acronym for design history file. The US FDA is the only country that specifically includes this in medical device regulations (i.e., 21 CFR 820.30j). Other countries simply require that you maintain records of design and development.
What is a DHF? - Medical Device Academy
2024年8月6日 · DHF is an acronym for design history file. The US FDA is the only country that specifically includes this in medical device regulations (i.e., 21 CFR 820.30j). Other countries simply require that you maintain records of design and development.
DHF/DMR/DHR的区别及各自应包含的文件 - czmed.com
2019年3月19日 · 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. In practice, 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。
What Is A DHF? - Zephyrnet
2024年8月6日 · DHF is an acronym for design history file. The US FDA is the only country that specifically includes this in medical device regulations (i.e., 21 CFR 820.30j). Other countries simply require that you maintain records of design and development.
The design history file (DHF) documents and describes the steps taken throughout the design process to create your medical device. The DHF is a record of the process including all plans, specifications, verification and validation tests and results, design reviews and closing events, and changes to the design. This file is.
第J节 设计历史文档 | 设计控制指南 - GitBook
设计历史文档——Design History Files，DHF. DHF的概念来源美国FDA，包含医疗器械（体外诊断试剂）的设计开发过程中创建的所有文档。 DHF应包含或引用的记录证据，以证明产品设计是根据批准的设计方案和法律法规的要求进行开发的。
- 某些结果已被删除