What Is Device Master Record (DMR) and Why Is It Important?
Device Master Record
A Device Master Record (DMR) is a collection of all the records that must be used to produce a medical device product.
设备主记录（DMR）是必须用于生产医疗器械产品的所有记录的集合。
Let’s imagine that your medical devices company is planning on manufacturing a new and improved coronary stent, which is a Class III medical device. You will need to record all the requisite information about the coronary stent including design requirements, specifications for production, quality assurance, packaging, labeling specifications, and others.
假设您的医疗器械公司计划制造一种新型和改进型的冠状支架，这是一种三类医疗器械。您需要记录有关冠状支架的所有必要信息，包括设计要求、生产规格、质量保证、包装、标签规格等。
The collection of these records is referred to as the Device Master Record (DMR).
这些记录的集合被称为设备主记录（DMR）。
In this article, you will learn about Device Master Record (DMR) and its regulatory requirements, how it differs from DMR and DHR. We will also discuss the importance of organizing your DMR properly, and how to manage it effectively using QMS software.
在本文中，您将了解设备主记录（DMR）及其监管要求，以及它与 DMR 和 DHR 的区别。我们还将讨论正确组织您的 DMR 的重要性，以及如何使用 QMS 软件有效管理它。
What is Device Master Record (DMR)? 设备主记录（DMR）是什么？
According to global regulatory agencies, your medical devices company must maintain all information and specifications related to the complete life cycle of every medical device produced. These centralized records are referred to as the Device Master Record (DMR) of that particular medical device.
根据全球监管机构的规定，您的医疗设备公司必须保留与每个生产的医疗设备的完整生命周期相关的所有信息和规格。这些集中记录被称为该特定医疗设备的设备主记录（DMR）。
The Device Master Record (DMR) contains appropriate drawings, material composition, specifications for the different components, the software required, quality assurance details, labeling, and packaging, as well as installation, maintenance, and servicing protocols.
设备主记录（DMR）包含适当的图纸、材料组成、不同组件的规格、所需软件、质量保证细节、标签和包装，以及安装、维护和服务协议。
What Is the Difference Between a DHF, DMR, and DHR? 什么是 DHF、DMR 和 DHR 之间的区别？
You are likely to get confused between a Design History File (DHF), Device Master Record (DMR), and a Device History Record (DHR). However, while they are similar sounding, they are quite different in the purposes they serve. Each one is a cornerstone of the design control process.
你很可能会对设计历史文件（DHF）、设备主记录（DMR）和设备历史记录（DHR）感到困惑。然而，尽管它们听起来相似，但它们在所服务的目的上有很大的区别。每个都是设计控制过程的基石。
Let us look briefly at each one to understand what their purpose is.
让我们简要地看一下每个，以了解它们的目的是什么。
Design History File (DHF) 设计历史文件（DHF）
Design History File (DHF) is a repository of all records that will outline the design history of a given medical device.
设计历史文件（DHF）是一个存储所有记录的库，将概述给定医疗设备的设计历史。
Let us look at the example of the coronary stent that your company is manufacturing.
让我们看一下你公司正在制造的冠状支架的例子。
The DHF for the coronary stent will give the necessary evidence to regulatory agencies that all design control procedures about it have been properly applied and documented.
冠状支架的 DHF 将为监管机构提供必要的证据，证明所有与其相关的设计控制程序已经得到正确应用和记录。
The DHF should contain:
DHF 应包括：
- Design plan
设计计划 - User requirement specifications
用户需求规范 - Validation activities
验证活动 - Component drawings
组件图纸 - Risk analysis
风险分析 - Etc. 等等。
Device Master Record (DMR) 设备主记录（DMR）
Device Master Record (DMR) will include all information needed for manufacturing the coronary stent.
设备主记录（DMR）将包括制造冠状支架所需的所有信息。
In the case of our previously given example, Device Master Record (DMR) should contain the following details:
在我们之前给出的例子中，设备主记录（DMR）应包含以下细节：
- Process and instrumentation diagrams
工艺和仪表图 - Construction material details
建筑材料细节 - Component details
组件细节 - Manufacturing details
制造细节 - Packaging details
包装细节 - Shelf-life of the coronary stent
冠状动脉支架的保质期 - Etc. 等等。
Device History Record (DHR) 设备历史记录（DHR）
During the production of the coronary stent, you will maintain a Device History Record (DHR) that will demonstrate to regulatory agencies that all requirements of the DMR have been fulfilled.
在冠状动脉支架的生产过程中，您将维护一个设备历史记录（DHR），以向监管机构证明已满足 DMR 的所有要求。
Basically, the DHR is record-keeping and serves to track the production process of every lot or batch of the coronary stent.
基本上，DHR 是记录和跟踪每个冠状支架批次或批次的生产过程的记录。
The DHR will contain:
DHR 将包含：
- Production records
生产记录 - Quantity manufactured
生产数量 - Quantity released for distribution
发行数量 - Acceptance records
验收记录 - Non-conformance reports
不符合报告 - The lot and serial number for every manufactured coronary stent 每个制造的冠状支架的批次和序列号
- Etc. 等等。
By using medical device QMS software it’s easy to maintain the structure of Design History File (DHF), Device Master Record (DMR), Device History Record (DHR). Furthermore, multiple documents and records can reside in multiple archives (DHF, DMR, DHR) at the same time without having to make duplicates of the same file.
通过使用医疗器械 QMS 软件，可以轻松维护设计历史文件（DHF），设备主记录（DMR），设备历史记录（DHR）的结构。此外，多个文档和记录可以同时驻留在多个存档（DHF，DMR，DHR）中，而无需制作相同文件的副本。
What Are the Requirements for Device Master Record? 设备主记录的要求是什么？
International regulatory agencies in the USA and the EU have specific requirements for the device master record to be maintained by your medical devices company.
美国和欧盟的国际监管机构对医疗设备公司维护设备主记录有特定要求。
FDA 21 CFR Part 820.181 states that:
FDA 21 CFR 第 820.181 条规定：
“Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40.”
“每个制造商应确保每个 DMR 按照 820.40 的规定进行准备和批准。”
The ISO 13485:2016 standard combines all documentation, including DHF and DMR in a single file referred to as “Medical Device File” (see section 4.2.3).
ISO 13485:2016 标准将所有文件，包括 DHF 和 DMR，合并为一个称为“医疗器械文件”的单个文件（参见 4.2.3 节）。
What Must the Device Master Record Include? 设备主记录必须包括什么？
According to the FDA 21 CFR Part 820.181, for example, as a coronary stent manufacturer, you must include the following details when you create a device master record for the coronary stent that you are manufacturing.
根据 FDA 21 CFR 第 820.181 条例，例如，作为冠状动脉支架制造商，您在为您正在制造的冠状动脉支架创建设备主记录时必须包括以下详细信息。
- Device specifications: These include appropriate drawings, composition, formulation, component specifications, and software specifications.
设备规格：包括适当的图纸、组成、配方、组件规格和软件规格。 - Product process specifications: These include the appropriate equipment specifications required to manufacture the coronary stent, methods of production, the procedures used during production, and the environment in which the coronary stents are to be manufactured.
产品工艺规格：包括制造冠状动脉支架所需的适当设备规格、生产方法、生产过程中使用的程序以及冠状动脉支架的制造环境。 - Quality assurance procedures and specifications: These include acceptance and rejection criteria and the type of quality assurance equipment that will be used.
质量保证程序和规范：这些包括验收和拒绝标准以及将使用的质量保证设备的类型。 - Packaging and labeling specifications: These include the methods and processes to be used for packaging and labeling of the manufactured product.
包装和标签规范：这些包括用于包装和标签制作的方法和流程。 - Installation, maintenance, and servicing protocols and methods.
安装、维护和服务协议和方法。 - Bill of Materials (BOM): This term is used to describe the complete ‘Parts List’ of all components that are needed to complete a saleable coronary stent.
物料清单（BOM）：这个术语用于描述完成可销售冠状支架所需的所有组件的完整“零件清单”。
While maintaining this information, you must realize that the DMR is the place wherein you link to all other data stores. This means that you will not keep everything in the DMR itself.
在保留这些信息的同时，您必须意识到 DMR 是您链接到所有其他数据存储的地方。这意味着您不会将所有内容都保存在 DMR 本身。
Therefore, as you start preparing the DMR, you will understand that efficient QMS software becomes essential. This is because QMS software provides document control features such as document search, version control, access controls, linking, and many others. Without such a software solution, it will become extremely difficult to maintain up-to-date and well-organized device master records.
因此，当您开始准备 DMR 时，您将了解到高效的 QMS 软件变得至关重要。这是因为 QMS 软件提供了文档控制功能，如文档搜索、版本控制、访问控制、链接等等。如果没有这样的软件解决方案，将变得非常难以维护最新和良好组织的设备主记录。
Importance of Proper Device Master Record (DMR) Maintenance 正确设备主记录（DMR）维护的重要性
The chief intention of the device master record is to centralize all records of the production of any given medical device that your company manufactures.
设备主记录的主要目的是将您公司制造的任何医疗设备的所有生产记录集中起来。
Let’s revisit the example of the coronary stent that your company is manufacturing.
让我们回顾一下您公司正在制造的冠状支架的例子。
It consists of three components:
它由三个组成部分组成：
- A platform which is stainless steel or cobalt-chromium
不锈钢或钴铬平台 - Active pharmacological drug agent
活性药物药剂 - Carrier vehicle
载体
Let’s imagine that there has been a failure with the cobalt-chromium platform of the coronary stent and complaints are raised.
假设冠状支架的钴铬平台发生故障并引发投诉。
Your device master record for the aforementioned coronary stent is impeccably maintained in QMS software. So, you are immediately able to access all relevant manufacturing information, including dates, batch numbers, approvals, etc. This enables you to immediately analyze and identify the defective batch or lot and deploy CAPA to resolve the issue.
您所提到的冠状动脉支架的设备主记录在 QMS 软件中被无可挑剔地维护。因此，您可以立即访问所有相关的制造信息，包括日期、批号、批准等。这使您能够立即分析和确定有缺陷的批次或批量，并部署 CAPA 来解决问题。
Here is an example of how the Device Master Record (DMR) for your coronary stent could be organized using QMS software like SimplerQMS:
以下是使用类似 SimplerQMS 的 QMS 软件组织冠状动脉支架的设备主记录（DMR）的示例：
- Declaration of conformity (DOC)
符合性声明（DOC） - Classification and intended use of the product
产品分类和预期用途 - Product specification and drawing specifications
产品规格和图纸规格 - Essential requirements
基本要求 - Risk management
风险管理 - Basic specifications
基本规范 - Product and process testing
产品和工艺测试 - Sterility testing
无菌测试 - Shelf life
货架寿命 - Product flowchart and BOM
产品流程图和 BOM - Quality control instructions and forms
质量控制指令和表格 - Information on components
零部件信息 - Instruction of use (IFU) and labeling
使用说明书（IFU）和标签 - Clinical files
临床档案 - Sales brochures
销售手册 - Change requests after the product are released
产品发布后的变更请求 - History of complaints
投诉历史 - CAPA history
CAPA 历史 - Literature on coronary stents
冠状支架文献 - Miscellaneous information
其他信息
Software for Managing Medical Device Technical Documentation 管理医疗器械技术文件的软件
International regulatory agencies such as the US FDA require that your device master record is compliant with FDA 21 CFR Part 820.181. This means that you must implement a robust document control system, with revision control, access controls, and other capabilities.
美国 FDA 等国际监管机构要求您的设备主记录符合 FDA 21 CFR 第 820.181 条款。这意味着您必须实施一个强大的文件控制系统，具有修订控制、访问控制和其他功能。
It is also important to maintain a central repository of all design controls used for the medical devices manufactured by your company.
同样重要的是，要维护一个集中存储库，用于存放贵公司制造的医疗器械所使用的所有设计控制。
Additionally, it’s worth remembering that the device master records will change and become more complex as time passes.
此外，值得记住的是，随着时间的推移，设备主记录将发生变化并变得更加复杂。
Looking at all these points, modern medical device QMS software with built-in document control features such as version control, access controls, electronic signatures, automated workflows, centralized repository, and others, become crucial for your medical device organization.
从所有这些要点来看，具有内置文档控制功能的现代医疗设备 QMS 软件，如版本控制、访问控制、电子签名、自动化工作流程、集中式存储库等，对于您的医疗设备组织至关重要。
QMS software like SimplerQMS, allows you to store all your medical device documents and records in one place. You will be able to easily link design and development documentation to specific products and components. Seamlessly maintain the DHF, DMR, and TF for each medical device your company manufactures.
像 SimplerQMS 这样的 QMS 软件，可以让您将所有医疗设备文档和记录存储在一个地方。您将能够轻松地将设计和开发文档与特定产品和组件相关联。无缝地维护您公司制造的每个医疗设备的 DHF、DMR 和 TF。
SimplerQMS helps you work most efficiently and save time and money, which are precious resources. Also, importantly, the software system helps you attain regulatory compliance with requirements applicable to medical device companies.
SimplerQMS 帮助您高效工作，节省时间和金钱，这些都是宝贵的资源。此外，重要的是，该软件系统帮助您达到适用于医疗设备公司的法规合规要求。
Final Thoughts 总结
The device master record is a regulatory requirement for all medical device companies. It is a repository of all essential information about your company’s medical devices and includes design requirements, production requirements, quality assurance requirements, packaging and labeling specifications, and other records.
设备主记录是所有医疗器械公司的法规要求。它是关于公司医疗器械的所有基本信息的存储库，包括设计要求、生产要求、质量保证要求、包装和标签规格以及其他记录。
With efficient QMS software such as SimplerQMS, your work becomes so much easier and efficient. It will become easier to stay in compliance with all the mandated requirements, save time and money.
通过像 SimplerQMS 这样高效的 QMS 软件，您的工作变得更加轻松和高效。它将更容易满足所有强制性要求，节省时间和金钱。
Ready to learn more about achieving efficiency in documentation processes in your medical device organization? Book a free demo today!
想要了解更多关于如何在医疗器械组织中实现文档处理效率的信息吗？立即预订免费演示！
References 参考文献
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