欧盟 MDR 质量管理体系

The tough part for the medical device industry is that this landscape of regulations is constantly changing, and therefore, intimidating. The European Union’s Medical Device Regulations (EU MDR) which came into effect on 26 May 2021 after a three-year transition period, is no exception.

医疗器械行业的困难在于监管环境不断变化，因此令人生畏。欧盟医疗器械法规（EU MDR）于 2021 年 5 月 26 日生效，经过三年的过渡期，这也不例外。

The EU MDR (formally, EU MDR 2017/745) replaced the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

EU MDR（正式为 EU MDR 2017/745）取代了欧盟的医疗器械指令（93/42/EEC）和欧盟的有源植入式医疗器械指令（90/385/EEC）。

When we look specifically at the Quality Management System (QMS) requirements, they are detailed in Article 10 (9) of EU MDR. For those companies familiar with the EU’s medical device QMS standard, EN ISO 13485:2016, the resemblance with Article 10(9) will immediately stand out.

具体来看质量管理体系（QMS）要求，它们在 EU MDR 的第 10 条（9）中有详细说明。对于熟悉欧盟医疗器械 QMS 标准 EN ISO 13485:2016 的公司来说，与第 10 条（9）的相似之处将立即显现。

In this article, we will take an in-depth look at what EU MDR is all about, the main QMS requirements, as well as the role of QMS software in supporting compliance with EU MDR regulations.

在这篇文章中，我们将深入了解欧盟医疗器械监管法规（EU MDR）的内容，主要的质量管理体系（QMS）要求，以及 QMS 软件在支持符合 EU MDR 法规方面的作用。

If you are keen on learning more about how a medical device eQMS system such as SimplerQMS can help your organization streamline quality management processes, make compliance with EU MDR easier, and stay ahead of your competitors – book a demo and talk to one of our experts today.

如果您对了解医疗器械电子质量管理体系（如 SimplerQMS）如何帮助您的组织简化质量管理流程，使符合 EU MDR 更加容易，并保持领先竞争对手感兴趣 - 请预约演示并与我们的专家交流。

What is EU MDR? 什么是欧盟 MDR

EU MDR stands for European Union Medical Device Regulations. It is a set of regulations governing both the production and distribution of medical devices in the European Union.

欧盟 MDR 代表欧洲联盟医疗器械法规。它是一套管理欧洲联盟医疗器械生产和分销的法规。

Medical device companies that plan to market their devices in the European Union, and require CE Marking, must comply with the regulations outlined in EU MDR.

计划在欧洲联盟市场销售其产品并需要 CE 标志的医疗器械公司必须遵守 EU MDR 中概述的法规。

Considering the importance of safety, quality, and efficacy of medical devices in the lives of end-users, the medical device industry must have in place an effective and efficient QMS. The EU MDR provides details for the overall responsibilities, procedures, and processes for Quality Management Systems.

考虑到医疗器械对最终用户的安全、质量和功效的重要性，医疗器械行业必须建立一个有效和高效的质量管理体系。EU MDR 提供了质量管理体系的总体责任、程序和流程的详细信息。

As a medical device manufacturer, you will need to have a set of EU MDR-compliant systems, documents, and processes that will continually monitor the safety, efficacy, and efficiency of your products. These regulations are pertinent for medical device manufacturers, importers, distributors of medical devices into the EU, and authorized representatives of medical device companies.

作为医疗器械制造商，您需要拥有一套符合 EU MDR 的系统、文件和流程，以持续监测产品的安全性、功效和效率。这些法规对医疗器械制造商、进口商、分销商以及医疗器械公司的授权代表都是相关的。

EU MDR vs EU MDD

The EU Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the European Union. It was replaced by the new regulation, EU MDR that is intended to both improve the safety and performance of medical devices used in Europe and to provide an increased level of protection for patients and users of these devices.

欧盟医疗器械指令（MDD）于 1994 年引入，以规范在欧洲联盟销售的医疗器械。它被新的法规欧盟 MDR 所取代，旨在提高欧洲使用的医疗器械的安全性和性能，并为患者和使用这些器械的用户提供更高水平的保护。

EU MDR continues to have all the requirements mentioned in MDD, with the addition of some new requirements.

与 MDD 相比，欧盟 MDR 仍具有所有提及的要求，并增加了一些新要求。

The key changes in EU MDR when compared to MDD are as follows.

与 MDD 相比，欧盟 MDR 的主要变化如下。

Stricter Classification of Medical Devices 医疗器械的分类更加严格

Medical device manufacturers, particularly those manufacturing devices that are to be used for surgeries, implantation, or other invasive procedures, including related software, must understand that the new classification of medical devices is now stricter.

医疗器械制造商，特别是那些制造用于手术、植入或其他侵入性程序的器械，包括相关软件的制造商，必须了解新的医疗器械分类现在更加严格。

For instance, medical devices that were under Class I of MDD will now come under Class 2a, at least.

例如，原来属于 MDD I 类的医疗器械现在至少属于 IIa 类。

MDR Annex VIII, Section 6 gives a comprehensive description of the new classification rules.

MDR 附件 VIII 第 6 节对新的分类规则进行了全面描述。

Furthermore, when the software drives a given medical device or plays a crucial role in the use of such a device, it will come under the same class as the device (refer to MDR Annex VIII, Chapter 2, Section 3.3).

此外，当软件驱动特定的医疗器械或在使用该器械中起关键作用时，它将与该器械属于同一类别（参见 MDR 附件 VIII 第 2 章第 3.3 节）。

Recommended Reading: Medical Device Classification (FDA & EU MDR)

推荐阅读：医疗器械分类（FDA 和欧盟 MDR）

Enhanced Traceability 增强可追溯性

EU MDR has introduced a Unique Device Identification (UDI) system that expedites easier traceability of medical devices.

欧盟医疗器械监管法规（EU MDR）引入了一种独特的医疗器械识别（UDI）系统，以加快医疗器械的追溯过程。

This system aims to provide several benefits including:

该系统旨在提供以下几个好处：

Reduction of medical errors 减少医疗错误
Tracing falsified devices 追踪伪造的器械
Improved purchasing and waste disposal 改善采购和废物处理
Improved post-market safety-related activities and monitoring 改善市场后安全相关活动和监测

The EU MDR’s Unique Device Identification (UDI) system is a distinctive numeric/alphanumeric code associated with a medical device. This UDI helps in the explicit identification of every device in the market. This facilitates their traceability.

欧盟医疗器械监管法规（EU MDR）的独特医疗器械识别（UDI）系统是与医疗器械相关的一个独特的数字/字母代码。这个 UDI 有助于明确识别市场上的每个器械，从而方便其追溯。

Changes in the Quality Management System (QMS) 质量管理体系（QMS）的变化

Under EU MDR regulations in Article 10, the scope of your medical device company’s QMS will now include protocols for clinically evaluating and operating a post-market surveillance (PMS) system.

根据欧盟 MDR 法规第 10 条，贵公司的医疗设备质量管理体系的范围现在将包括临床评估和上市后监测（PMS）系统的协议。

Additionally, a post-market clinical follow-up (PMCF) is required for every product you manufacture.

此外，每个您生产的产品都需要进行上市后临床跟踪（PMCF）。

Requirements for Notified Bodies 通知机构的要求

Annex VII (Requirements to be met by Notified Bodies) of EU MDR highlights requirements for the designation of Notified Bodies.

欧盟 MDR 的附件 VII（通知机构必须满足的要求）强调了通知机构的指定要求。

This means that every Notified Body must be set up in accordance with a member state’s national laws. Complete documentation should be available for the legality and the status of such a Notified Body.

这意味着每个通知机构必须按照成员国的国家法律设立。应该提供完整的文件以证明该通知机构的合法性和地位。

These Notified Bodies must also provide information on their ownership.

这些通知机构还必须提供其所有权的信息。

Need for an Independent Expert Panel 需要独立专家小组

When your company’s medical device comes under Classes IIa, IIb, or III, you will need to involve a Notified Body for conformity assessment. Notified Bodies are required to consult with expert panels before clearing certain high-risk devices.

当您公司的医疗设备属于 IIa、IIb 或 III 类时，您需要与通知机构进行符合性评估。在清除某些高风险设备之前，通知机构需要与专家小组进行咨询。

This is obligatory when a Class III device is intended for implantation.

当 III 类设备用于植入时，这是强制性的。

Improved Transparency 提高透明度

Under EU MDR regulations, information on all medical device products and tests is now in the public domain.

根据欧盟 MDR 法规，所有医疗器械产品和测试的信息现在都在公共领域中。

The European Electronic Database for Medical Device Information (EUDAMED) will provide a clear-cut picture of all devices that are available in the EU market.

欧洲医疗器械信息电子数据库（EUDAMED）将提供欧盟市场上所有可用设备的清晰图像。

This will help with transparency and assist coordination between the EU Member States.

这将有助于透明度，并促进欧盟成员国之间的协调。

Rigorous Clinical Evaluation Requirements 严格的临床评估要求

Clinical evaluation requirements are now tightened up under EU MDR regulations.

这些包括临床数据收集和临床研究的组织。

These include clinical data collection and the organization of clinical studies.

根据欧盟 MDR 法规，临床评估要求现在已经加强。

Implantable medical devices and Class III devices are required to undergo clinical trials before being marketed. For certain Class IIb and Class III devices that are used for drug management (within/outside the body), the medical device company has the option of consulting specified EU experts regarding a clinical development plan.

在上市之前，植入式医疗器械和 III 类医疗器械需要进行临床试验。对于某些用于药物管理（体内/体外）的 IIb 和 III 类医疗器械，医疗器械公司可以选择咨询指定的欧盟专家以制定临床发展计划。

What is The Purpose of EU MDR? 欧盟 MDR 的目的是什么？

The purpose of EU MDR regulations is to improve the safety and performance of medical devices used in the European Union. With the implementation of these regulations, your company and the regulatory agencies will ensure that there is enhanced protection for the end-users of your company’s medical devices.

欧盟 MDR 法规的目的是提高在欧盟使用的医疗器械的安全性和性能。通过实施这些法规，贵公司和监管机构将确保对贵公司医疗器械的最终用户提供增强保护。

For instance, if you doubt how to classify tracheotomy tubes and blood bags that you manufacture and intend to sell in the EU, the new regulations clearly state that blood bags come under Class IIb (Medium/High risk) and tracheotomy tubes will come under Class IIa (Medium Risk).

例如，如果您对贵公司生产和打算在欧盟销售的气管切开管和血袋的分类有疑问，新法规明确规定血袋属于 IIb 类（中/高风险），气管切开管属于 IIa 类（中风险）。

Another example there are reports of drug-coated stents causing serious health hazards in patients. On investigation, these stents have been identified as counterfeit. Based on their UDI (Unique Device Identification) number, it becomes easier for regulatory authorities to trace them back to the manufacturer.

另一个例子是有报道称药物涂层支架在患者身上引起严重的健康危害。经调查，这些支架被确认为假冒产品。根据它们的 UDI（唯一设备识别）编号，监管机构可以更容易地追溯到制造商。

When it comes to complying with EU MDR regulations, the use of traditional paper-based or hybrid QMS systems comes with its own set of challenges – storage, security, human errors, traceability, and costs, to name a few.

在遵守欧盟 MDR 法规方面，传统的纸质或混合型 QMS 系统使用会带来一系列挑战 - 存储、安全、人为错误、可追溯性和成本等等。

On the other hand, an electronic QMS made for medical devices such as SimplerQMS helps you manage and control all your quality processes in one place. From design and development to post-market surveillance, our medical device quality management software is equipped with the necessary tools and features to support your EU MDR compliance journey.

另一方面，专为医疗设备而设计的电子 QMS，如 SimplerQMS，可以帮助您在一个地方管理和控制所有质量流程。从设计和开发到市场后监测，我们的医疗设备质量管理软件配备了必要的工具和功能，以支持您的欧盟 MDR 合规之旅。

EU MDR QMS Requirements 欧盟 MDR 质量管理体系要求

As mentioned earlier, the QMS requirements for your medical device company are given in detail in Article 10 (9) of the current EU MDR.

如前所述，您的医疗器械公司的质量管理体系（QMS）的要求在当前欧盟 MDR 的第 10 条（9）中详细说明。

Let us now deep dive into the indispensable aspects that your medical device quality management system (QMS) must address.

现在让我们深入探讨您的医疗器械质量管理体系（QMS）必须解决的不可或缺的方面。

Throughout this section, you will also observe that various examples are provided showing how a modern electronic QMS will streamline these processes.

在本节中，您还将观察到提供了各种示例，展示了现代电子 QMS 如何简化这些流程。

Note

Please note that the following details are by no means a comprehensive guide to EU MDR QMS requirements. Your medical device company should always follow the official applicable requirements.

请注意，以下细节绝不是欧盟MDR QMS要求的全面指南。您的医疗器械公司应始终遵循官方适用要求。

1. Regulatory Compliance 法规合规

Your medical device company’s QMS must have a policy for regulatory compliance.

您的医疗器械公司的质量管理体系必须有一个法规合规政策。

This means that you will adhere to the laws, regulations, guidelines, and specifications that are relevant to your industry.

这意味着您将遵守与您所在行业相关的法律、法规、指南和规范。

For instance, the EU MDR clearly states that intra-ocular lenses come under Class IIb (Medium to High Risk). When your company is marketing these devices in the European market, you have to comply with the guidelines. You cannot market this product as Class IIa (Medium risk) or Class I (Low risk).

例如，欧盟 MDR 明确规定，眼内镜属于 IIb 类（中高风险）。当您的公司在欧洲市场推广这些设备时，您必须遵守指南。您不能将此产品市场定位为 IIa 类（中风险）或 I 类（低风险）。

2. Conformity of Devices 设备的一致性

Your medical device company should ensure that all devices that are in production conform.

您的医疗设备公司应确保所有正在生产的设备符合规定。

According to this regulation, you have to maintain records and documents that show evidence that all products manufactured by your company exactly match the specifications, performance, and safety criteria applicable to that device.

根据这项规定，您必须保留记录和文件，以证明您公司生产的所有产品与该设备适用的规格、性能和安全标准完全相符。

If there are any changes, irrespective of changes in design or the harmonized standards must be attended to in a time-bound manner.

如果有任何变更，无论是设计变更还是协调标准的变更，都必须按时处理。

For instance, the intra-ocular lenses that you manufacture are made of silicone. Due to supply issues, you have decided to manufacture them out of acrylic, for which a 3rd party supplier is available. Such a change in the design must be immediately documented and the reasons explained.

例如，您制造的眼内镜片是由硅胶制成的。由于供应问题，您决定改用丙烯酸制造，可以从第三方供应商那里获得。设计上的这种变化必须立即记录并解释原因。

By streamlining your quality management processes with modern QMS software with robust change management capabilities like SimplerQMS, you can easily keep track of all changes made to your products, devices, and processes.

通过使用像 SimplerQMS 这样具有强大变更管理功能的现代 QMS 软件来简化您的质量管理流程，您可以轻松跟踪对产品、设备和流程所做的所有更改。

Recommended Reading

3. Management Responsibility\ 管理责任

According to EU MDR regulations, the senior management of your company should show commitment towards the development and implementation of an effective QMS in accordance with EU MDR.

根据欧盟 MDR 法规，贵公司的高级管理层应该展示对根据欧盟 MDR 要求开发和实施有效 QMS 的承诺。

What does this mean?

这是什么意思？

Your senior management must communicate with all employees the importance of the customer and regulatory requirements outlined in the regulations. Not only are you required to establish the company’s quality policy, but you must also establish the objectives, provide resources, and conduct reviews in a timely manner.

贵公司的高级管理层必须与所有员工沟通法规中概述的客户和监管要求的重要性。您不仅需要建立公司的质量方针，还需要制定目标，提供资源，并及时进行审查。

SimplerQMS software provides your company with a centralized repository that is a single source of truth for quality data. With this repository, you can manage all types of documents or files that will help you keep an overall check over the company’s QMS.

SimplerQMS 软件为您的公司提供了一个集中的存储库，这是质量数据的唯一真实来源。通过这个存储库，您可以管理所有类型的文件或文件，以帮助您对公司的 QMS 进行全面检查。

Moreover, this single source of data can be used for the creation of trending reports, such as CAPAs (open/closed), non-conformances (open/closed), training assignments (on time/overdue), and so on.

此外，这个数据的唯一来源可以用于创建趋势报告，如 CAPAs（开放/关闭），不符合（开放/关闭），培训任务（按时/逾期）等等。

All this information will be most useful during your management reviews.

所有这些信息在您的管理审查中将非常有用。

4. Resource Management and Control of Suppliers 供应商的资源管理和控制

Your QMS must include resource management methodologies, including information on selecting and control of suppliers and sub-contractors.

您的 QMS 必须包括资源管理方法，包括选择和控制供应商和分包商的信息。

Your QMS must highlight the resources required for the effective implementation of EU MDR. These resources will be both human resources (trained and competent personnel) and infrastructure resources (equipment, space, information systems, and so on).

您的 QMS 必须突出 EU MDR 有效实施所需的资源。这些资源既包括人力资源（经过培训和胜任的人员），也包括基础设施资源（设备、空间、信息系统等）。

With the SimplerQMS software solution, you can ensure that all your suppliers are selected following pre-defined criteria. Furthermore, you will be able to make sure that your employees have received the proper training following current SOPs and quality protocols.

通过 SimplerQMS 软件解决方案，您可以确保所有供应商都是根据预定义的标准进行选择的。此外，您还将能够确保您的员工按照当前的 SOP 和质量协议接受了适当的培训。

Recommended Reading: Medical Device Supplier Management Process (8 Steps)

推荐阅读：医疗器械供应商管理过程（8 个步骤）

5. Risk Management 风险管理

Risk management is an essential component of EU MDR compliance.

风险管理是欧盟 MDR 合规的重要组成部分。

All medical devices must be designed, manufactured, and packaged taking into account the purpose the device is intended for.

所有医疗器械必须在设计、制造和包装时考虑到设备的预期用途。

For instance, the intra-ocular lens we spoke about earlier must be packaged in such a manner that its sterility is maintained. You will not want the lens to inadvertently cause any infection because of a lack of sterility at your end.

例如，我们之前提到的眼内镜必须以一种方式包装，以保持其无菌性。您不希望镜片因为您这边缺乏无菌性而意外引起任何感染。

A modern QMS software solution should be able to help you accelerate the development of your medical devices, including the processes of verification, validation, and design transfer. All the necessary documentation concerning product realization and risk management would be stored in a centralized repository and easily accessed via highly customizable dashboards.

现代的 QMS 软件解决方案应该能够帮助您加快医疗设备的开发，包括验证、确认和设计转移的过程。所有与产品实现和风险管理有关的必要文件将存储在集中的存储库中，并可以通过高度可定制的仪表板轻松访问。

Recommended Reading: Design Controls for Medical Devices

推荐阅读：医疗设备的设计控制

6. Clinical Evaluation Data and Post-Market Clinical Follow-Up 临床评估数据和上市后临床跟踪

This is a systematic and planned process by which your company will assess the safety and performance of every medical device that you manufacture and market.

这是您的公司将评估您制造和销售的每个医疗设备的安全性和性能的系统性和计划性过程。

The chief intent of this aspect of EU MDR QMS is to exhibit conformity with the General Safety and Performance Requirements (GSPRs). GSPRs are listed in Annex I of EU MDR and include the intended purpose of the medical device, patient safety, risk control, device properties, and others.

EU MDR QMS 的这个方面的主要目的是展示符合《欧盟医疗器械法规》（GSPRs）的一般安全性和性能要求。GSPRs 列在《欧盟医疗器械法规》的附件 I 中，包括医疗设备的预期用途、患者安全、风险控制、设备属性等。

For instance, the intra-ocular lenses that you manufacture are meant to be safe and efficacious for your customers. An unfortunate series of incidents take place wherein these lenses result in adverse events. You are obliged to find out the reasons and ensure that they do not repeat.

例如，您制造的眼内镜片旨在为您的客户提供安全有效的产品。不幸的是，一系列事件发生，导致这些镜片引发了不良事件。您有责任找出原因，并确保不再发生。

With a modern QMS software solution like SimplerQMS, you will be able to continuously collect and monitor data generated from every medical device that is placed on the market. The data may be, for example, in the form of customer complaints, non-conformances, or adverse event reports.

通过像 SimplerQMS 这样的现代化质量管理软件解决方案，您将能够持续收集和监控市场上每个医疗设备产生的数据。这些数据可能以客户投诉、不符合要求或不良事件报告的形式存在。

7. Upholding UDI Standards 坚持 UDI 标准

Your medical device company’s quality management system must be able to make sure that the UDI for all your devices is verifiable, and you should also be able to ensure consistency and validity.

您的医疗器械公司的质量管理体系必须能够确保所有设备的 UDI 可验证，并且您还应该能够确保一致性和有效性。

It goes without saying that spurious medical devices will play havoc with the lives of patients. It is also true that such devices are likely to be labeled with the details of a genuine company, which will then get into the crosshairs of regulatory agencies.

不用说，伪造的医疗器械会给患者的生活带来混乱。同样，这种设备很可能会被标有真实公司的详细信息，然后成为监管机构关注的焦点。

How do you safeguard your medical devices?

您如何保护您的医疗器械？

This is possible with the Unique Device Identification (UDI) for every medical device that you manufacture and market. As mentioned previously, the EU MDR’s UDI system provides exclusive numeric/alphanumeric codes for every authentic medical device in the market. This will help trace each and every medical device.

通过为您制造和销售的每个医疗器械提供独特的设备识别码（UDI），这是可能的。如前所述，欧盟 MDR 的 UDI 系统为市场上的每个真实医疗器械提供了独特的数字/字母代码。这将有助于追踪每个医疗器械。

8. Communication Protocols 通信协议

How well you communicate with competent authorities, Notified Bodies, customers, and other stakeholders will reflect on your QMS.

您与主管机构、通知机构、客户和其他利益相关方的沟通能力将反映在您的质量管理体系上。

For instance, you should be sure of the regulatory needs for every medical device that your company manufactures, and engage a Notified Body as required. When your regulatory affairs department does it efficiently, you will be meeting the requirements and expectations of the Notified Body.

例如，您应确保您的公司制造的每种医疗器械的监管需求，并根据需要与通知机构合作。当您的监管事务部门高效处理时，您将满足通知机构的要求和期望。

Annex VII of the EU MDR refers to requirements to be met by Notified Bodies.

欧盟 MDR 的附件 VII 涉及通知机构需要满足的要求。

The NANDO (New Approach Notified and Designated Organizations) database contains the list of notified bodies, their identification number, contact details, and the tasks for which they have been notified, including medical device CE marking.

NANDO（新方法通知和指定组织）数据库包含通知机构的列表、其识别号码、联系方式以及它们已被通知的任务，包括医疗器械 CE 标志。

9. CAPA Management CAPA 管理

Your QMS system should have processes and protocols in place for managing corrective actions and the verification of their effectiveness.

您的 QMS 系统应该有流程和协议来管理纠正措施和验证其有效性。

Let us take for instance the intra-ocular lenses that you market in the European Union. Your Quality Department has received complaints from two locations that the sterility of some of these lenses is compromised. This is a serious issue that must be investigated with full vigor and CAPA generated.

让我们以您在欧盟市场上销售的眼内镜为例。您的质量部门收到了来自两个地点的投诉，称某些镜片的无菌性受到了损害。这是一个严重的问题，必须全力调查并生成 CAPA。

With the CAPA management solution built into QMS software like SimplerQMS, you are assured of more streamlined CAPA management processes. You will be able to recognize and initiate CAPAs, recognize trends, conduct a root cause analysis, initiate actions, as well as verify and close the case with ease.

通过像 SimplerQMS 这样的 QMS 软件内置的 CAPA 管理解决方案，您可以确保更加简化的 CAPA 管理流程。您将能够识别和启动 CAPA，识别趋势，进行根本原因分析，启动行动，以及轻松验证和关闭案件。

Recommended Reading: What Is CAPA in the Medical Device Industry?

推荐阅读：医疗器械行业中的 CAPA 是什么？

The Role of QMS Software in Supporting Compliance with EU MDR QMS 软件在支持符合欧盟 MDR 方面的作用

When you consider all the EU MDR requirements that were elaborated on in the previous section, you will realize that a traditional paper-based documentation system or a hybrid system will not suffice. They have their own set of challenges, including issues of human error, security, safety, storage, and the burgeoning costs of paper, files, printing, and so on…

当您考虑到前一节中详细阐述的所有欧盟 MDR 要求时，您会意识到传统的纸质文档系统或混合系统是不够的。它们有自己的一系列挑战，包括人为错误、安全性、安全性、存储以及纸张、文件、打印等不断增长的成本问题…

Considering the importance of compliance with EU MDR regulations, your company, just like many other medical device companies nowadays should opt for a modern electronic QMS software solution.

考虑到符合欧盟 MDR 法规的重要性，您的公司，就像现在许多其他医疗器械公司一样，应选择现代化的电子 QMS 软件解决方案。

With such a quality management solution in place, you will have all the provisions for maintaining compliance with EU MDR, streamlining your operations, increasing efficiency, lowering costs, and being able to confidently market your products in the European Union.

有了这样一个质量管理解决方案，您将拥有所有维持符合欧盟 MDR 的规定的条件，优化您的运营，提高效率，降低成本，并能够自信地在欧盟市场推广您的产品。

The best QMS software solutions on the market will offer you comprehensive and robust modules for document control, change management, training management, CAPA management, customer complaints, audits, and much more.

市场上最好的 QMS 软件解决方案将为您提供全面而强大的模块，用于文档控制、变更管理、培训管理、CAPA 管理、客户投诉、审计等等。

Centralized, cloud-based QMS solutions will offer you even more benefits with their anytime, anywhere access, automatic updates, and the ability to integrate with other enterprise software solutions.

集中化、基于云的 QMS 解决方案将通过随时随地的访问、自动更新以及与其他企业软件解决方案的集成能力，为您带来更多的好处。

Furthermore, features like, automated document routing, document versioning, version control, electronic signatures, time-stamped audit trails, access controls, and permissions will all contribute to the success of your compliance with various regulatory standards and guidelines.

此外，自动化文档路由、文档版本控制、电子签名、时间戳审计追踪、访问控制和权限等功能，都将有助于您符合各种监管标准和指南的成功。

Medical device QMS software by SimplerQMS is an excellent example of such a solution that offers you all the features and benefits that we have elaborated on.

SimplerQMS 的医疗设备 QMS 软件是这样一个解决方案的绝佳示例，它为您提供了我们所详述的所有功能和优势。

SimplerQMS is a modern, cloud-based quality management software that helps companies in various industries streamline their operations and remain compliant with multiple standards and guidelines, including the EU MDR.

SimplerQMS 是一款现代化的基于云的质量管理软件，可帮助各行各业的公司简化运营并符合多个标准和指南，包括欧盟 MDR。

If you would like to assess whether investing in a quality management software solution is the best course of action for your company, then we suggest you download our eQMS Business Case template. It helps quantify the value of investing in quality management software for your business, and present it to decision-makers in your company.

如果您想评估是否投资于质量管理软件解决方案是您公司的最佳行动方案，那么我们建议您下载我们的 eQMS 商业案例模板。它有助于量化您公司投资质量管理软件的价值，并向您公司的决策者展示。

Conclusion 总结

Medical device companies are amongst the most highly regulated in the life science industry. This is essential considering that medical devices play such a huge role in the lives of patients.

医疗器械公司是生命科学行业中受监管最严格的公司之一。考虑到医疗器械在患者生活中起着如此重要的作用，这是必不可少的。

If your medical device company wants to manufacture and market in the EU, you must be compliant with the EU MDR guidelines which have replaced the EU MDD with effect from 26 May 2021.

如果您的医疗器械公司希望在欧盟制造和销售产品，您必须符合欧盟 MDR 指南，该指南已于 2021 年 5 月 26 日取代了欧盟 MDD。

When you look specifically at the QMS requirements for medical device companies, you must be thorough with Article 10 (9) of EU MDR.

当您具体查看医疗器械公司的质量管理体系要求时，您必须对欧盟 MDR 的第 10 条（9）进行全面了解。

Traditional paper-based or hybrid QMS systems have no place in modern organizations because of their inherent difficulties and challenges. If you are keen on investing in an eQMS solution to streamline your QMS processes and make compliance with EU MDR easier, book a demo of SimplerQMS and talk to our quality solution experts today.

传统的纸质或混合型质量管理体系在现代组织中已经没有了位置，因为它们固有的困难和挑战。如果您有意投资于电子质量管理体系解决方案，以简化质量管理体系流程并更容易符合欧盟 MDR 的要求，请预约 SimplerQMS 的演示，并与我们的质量解决方案专家进行交流。

References 参考文献

EU MDR Quality Management System [Role of an eQMS Software]