Medical Device Quality Management System (QMS) 医疗器械质量管理体系

医疗器械质量管理体系

A Medical Device Quality Management System (QMS) is a set of policies, processes, and procedures that a manufacturer of medical devices has in place to ensure that their products are safe and effective for their intended use.

医疗器械质量管理体系（QMS）是一套政策、流程和程序，制造医疗器械的厂商采用这套体系以确保其产品在预期使用中安全有效。

The QMS includes all aspects of design and development, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and other areas.

QMS 包括设计和开发、制造、供应商管理、风险管理、投诉处理、临床数据、储存、分销、产品标签和其他方面的所有内容。

Medical devices have different classes based on their risk to the end user. Specific regulatory requirements are applicable depending on the device classification to ensure safe and reliable products.

医疗器械根据对最终用户的风险不同而分为不同的类别。根据设备分类，适用特定的监管要求以确保产品安全可靠。

A medical device QMS needs to reflect the applicable requirements of a company’s processes to help ensure regulatory compliance.

医疗设备 QMS 需要反映公司流程的适用要求，以帮助确保符合法规。

This article will discuss a medical device quality management system, its purpose, some of the main regulatory requirements, and the role of an eQMS in helping streamline processes and maintain a compliant medical device quality system.

本文将讨论医疗设备质量管理系统，其目的，一些主要的法规要求，以及 eQMS 在帮助简化流程和维护符合法规的医疗设备质量体系方面的作用。

SimplerQMS provides medical device QMS software. Our solution includes all QMS modules into one system to streamline processes, including document control, change control, employee training, audits, nonconformance, CAPA management, and much more.

SimplerQMS 提供医疗设备 QMS 软件。我们的解决方案将所有 QMS 模块整合到一个系统中，以简化流程，包括文件控制，变更控制，员工培训，审计，不符合，CAPA 管理等等。

If you are interested in discovering how your company can benefit from SimplerQMS, book a personalized demo and talk with our software experts.

如果您有兴趣了解您的公司如何从 SimplerQMS 中受益，请预订个性化演示并与我们的软件专家交流。

What Is a Medical Device Quality Management System (QMS)? 什么是医疗器械质量管理体系？

A Medical Device Quality Management System (QMS) is a structured system that documents the procedures and processes implemented throughout the lifecycle of a medical device.

医疗器械质量管理体系（QMS）是一个结构化的系统，记录了医疗器械在整个生命周期中实施的程序和流程。

A medical device QMS is essential to ensure quality in developing, manufacturing, and distributing processes.

医疗器械质量管理体系对于确保开发、制造和分销过程中的质量至关重要。

As a manufacturer of medical devices planning to sell your products in the international market, you are required to implement and maintain a quality management system compliant with applicable international and national standards, guidelines, and regulations.

作为一家计划在国际市场销售医疗设备的制造商，您需要实施和维护符合适用的国际和国家标准、指南和法规的质量管理体系。

This requires establishing quality processes and assigning responsibilities, resources, and timeframes for each process.

这需要建立质量流程，并为每个流程分配责任、资源和时间框架。

Some of the main QMS processes for medical device manufacturers include document control, change control, employee training, audit management, CAPA, supplier management, risk management, and complaint handling.

医疗设备制造商的主要质量管理体系流程包括文件控制、变更控制、员工培训、审计管理、CAPA、供应商管理、风险管理和投诉处理。

Quality Management System (QMS) can be implemented using paper documents or eQMS software.

质量管理体系（QMS）可以使用纸质文件或 eQMS 软件来实施。

Medical device manufacturers can manually manage their QMS if they have the resources to handle manual paperwork.

如果医疗器械制造商有资源处理手工文件工作，他们可以手动管理他们的 QMS。

But with the increasing number and complexity of regulatory requirements, managing all quality processes relying on manual paperwork can become challenging.

但是随着法规要求的数量和复杂性的增加，依靠手工文件工作来管理所有质量流程可能变得具有挑战性。

Many companies are migrating to eQMS and taking advantage of the benefits, including improved workflows, reduced time and costs, and cloud-based document storage.

许多公司正在迁移到 eQMS，并利用其优势，包括改进的工作流程，减少的时间和成本以及基于云的文档存储。

SimplerQMS offers an eQMS solution designed for the medical device industry to help companies streamline their quality processes and achieve compliance. We provide interconnected QMS modules for more streamlined control and management of documents, changes, employee training, nonconformances, CAPAs, suppliers, and many other processes.

SimplerQMS 提供了一种专为医疗器械行业设计的 eQMS 解决方案，以帮助公司简化其质量流程并实现合规性。我们提供相互连接的 QMS 模块，用于更加简化的文档控制和管理、变更、员工培训、不符合、CAPA、供应商和许多其他流程。

Purpose of Medical Device Quality Management System 医疗器械质量管理体系的目的

The purpose of a medical device quality management system is to ensure that products are safe and effective for their intended use.

医疗器械质量管理体系的目的是确保产品在其预期使用中安全有效。

A QMS provides a framework for consistent and documented processes throughout the product lifecycle, from design and development to post-market surveillance.

质量管理体系为产品的整个生命周期提供了一套一致且有文档记录的流程框架，从设计和开发到市场后监测。

Implementing and maintaining a QMS for medical devices is critical for manufacturers seeking approval from regulatory authorities in their intended market.

对于寻求在预期市场获得监管机构批准的制造商来说，实施和维护医疗器械质量管理体系至关重要。

In Europe, having a QMS is required to obtain the CE marking and be able to sell your device across the European Economic Area. It is necessary to achieve compliance with the applicable EU regulations, such as the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).

在欧洲，拥有 QMS 是获得 CE 标志并能够在欧洲经济区销售设备的必要条件。必须符合适用的欧盟法规，如医疗器械法规（MDR）或体外诊断法规（IVDR）。

You can learn more about how to obtain CE marking for medical devices in our step-by-step guide.

您可以在我们的逐步指南中了解有关如何获得医疗器械 CE 标志的更多信息。

The Food and Drug Administration (FDA) has set forth current good manufacturing practice (cGMP) requirements for medical device quality management systems in the United States.

美国食品和药物管理局（FDA）已制定了对医疗器械质量管理体系的当前良好制造规范（cGMP）要求。

These requirements are outlined in the 21 CFR Part 820, also known as Quality System Regulation (QSR). They must be implemented throughout the product lifecycle.

这些要求概述在 21 CFR 第 820 部分，也被称为质量体系规定（QSR）。必须在产品生命周期中实施。

International Standards and Regulations Governing Medical Device QMS 国际标准和法规管理医疗器械质量管理体系

There are numerous international standards and regulations governing medical device quality management systems.

有许多国际标准和法规管理医疗器械质量管理体系。

This article will focus on two major international markets, Europe and the United States.

本文将重点介绍两个主要的国际市场，欧洲和美国。

Medical device manufacturers marketing and selling in the EU will most likely comply with ISO 13485:2016 standard, MDR, and IVDR for requirements for quality management systems.

在欧盟市场销售的医疗器械制造商很可能符合 ISO 13485:2016 标准、MDR 和 IVDR 的质量管理体系要求。

On the other hand, manufacturers selling in the US will comply with the FDA’s regulation 21 CFR Part 820, also known as Quality System Regulations (QSR).

另一方面，在美国销售的制造商将遵守 FDA 的 21 CFR 第 820 条规定，也被称为质量体系规定（QSR）。

Let’s take a brief look at the major standards and regulations that you must be aware of:

让我们简要了解一下您必须了解的主要标准和法规：

• ISO 13485:2016 Standard ISO 13485:2016 标准
• Medical Device Regulation (MDR) 医疗器械法规（MDR）
• In Vitro Diagnostic Regulation (IVDR) 体外诊断法规（IVDR）
• FDA 21 CFR Part 820 Regulation FDA 21 CFR 第 820 条规定

ISO 13485:2016 Standard

The International Organization for Standardization (ISO) is responsible for the international regulatory standard ISO 13485:2016. It specifies the requirements for a QMS that can be used by organizations involved in the life cycle of a medical device.

国际标准化组织（ISO）负责国际监管标准 ISO 13485:2016。它规定了一个医疗器械生命周期中可以被组织使用的质量管理体系的要求。

Manufacturers that comply with this standard demonstrate their ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements.

符合该标准的制造商展示了他们提供医疗器械和相关服务，以不断满足客户和适用的监管要求的能力。

You can read our article to learn more about an ISO 13485:2016 compliant QMS. It discusses the purpose of the ISO 13485:2016 standard, the main QMS requirements, and the role of eQMS in supporting compliance.

您可以阅读我们的文章，了解更多关于符合 ISO 13485:2016 的质量管理体系的信息。它讨论了 ISO 13485:2016 标准的目的，主要的质量管理体系要求，以及电子质量管理体系在支持合规性方面的作用。

And if you want to know specifically about audits, check out our ISO 13485:2016 audits article for an overview of different types of audits and the execution process.

如果您想了解有关审计的具体信息，请查看我们的 ISO 13485:2016 审计文章，了解不同类型的审计和执行过程的概述。

Medical Device Regulation (MDR)

The Medical Devices Regulation (MDR), or EU 2017/745, specifies the requirements for designing, manufacturing and distributing medical devices and accessories for human use in the EU.

医疗器械法规（MDR）或 EU 2017/745 规定了在欧盟设计、制造和分销医疗器械和人体用品的要求。

The MDR requires medical device manufacturers to establish and maintain a comprehensive QMS to ensure compliance.

MDR 要求医疗器械制造商建立和维护全面的质量管理体系以确保合规性。

Although not mandatory in the MDR, manufacturers often use compliance with the ISO 13485:2016 standard since it presumes compliance with QMS requirements presented in the regulation. Which can help speed up the MDR certification process.

虽然在 MDR 中并非强制要求，但制造商通常使用符合 ISO 13485:2016 标准，因为它假定符合法规中提出的质量管理体系要求。这有助于加快 MDR 认证过程。

You can learn more about this regulation by reading our article on EU MDR Quality Management System.

您可以通过阅读我们关于欧盟 MDR 质量管理体系的文章来了解更多信息。

In Vitro Medical Device Regulation (IVDR)

The In Vitro Diagnostic Medical Devices Regulation (IVDR) is the most common way to refer to Regulation (EU) 2017/746.

体外诊断医疗器械监管（IVDR）是指（EU）2017/746 法规的最常见方式。

The IVDR has more stringent requirements for manufacturers of in vitro diagnostic devices, including a focus on risk-based classification, performance evaluation, and post-market surveillance.

IVDR 对体外诊断器械制造商有更严格的要求，包括风险分类、性能评估和市场后期监测的重点。

It also requires manufacturers of in vitro diagnostic devices to implement a QMS that ensures compliance with the essential principles of safety and performance.

它还要求体外诊断器械制造商实施确保符合安全和性能基本原则的质量管理体系。

Like the MDR, the IVDR also recognizes compliance with ISO 13485:2016 for QMS requirements.

与 MDR 一样，IVDR 也承认符合 ISO 13485:2016 的质量管理体系要求。

Feel free to read our article to learn more about EU IVDR in a detailed introduction.

欢迎阅读我们的文章，详细了解欧盟 IVDR。

FDA 21 CFR Part 820 Regulation

The 21 CFR Part 820 is a regulation of the US Food and Drug Administration (FDA) that outlines the Quality System Regulation (QSR) requirements for medical device manufacturers.

21 CFR 第 820 部分是美国食品药品监督管理局（FDA）的一项法规，概述了医疗器械制造商的质量体系规定（QSR）要求。

This regulation specifies the minimum requirements for a medical device QMS to ensure that devices are safe and effective for their intended use.

该法规规定了医疗器械质量管理体系（QMS）的最低要求，以确保设备在其预期用途中安全有效。

Compliance with 21 CFR Part 820 is mandatory for all medical device manufacturers who wish to sell their products in the US market.

符合 21 CFR 第 820 部分的要求对于所有希望在美国市场销售其产品的医疗器械制造商来说是强制性的。

Our article on the FDA 21 CFR Part 820 Quality System Regulation – provides more information regarding this regulation and the role of eQMS in supporting compliance.

我们关于 FDA 21 CFR 第 820 部分质量体系规定的文章提供了更多关于该法规以及电子质量管理体系（eQMS）在支持合规方面的信息。

Additionally, other requirements must be considered when implementing a quality management system using a computer system, such as QMS software or an eQMS.

此外，在使用计算机系统实施质量管理系统（如 QMS 软件或 eQMS）时，还必须考虑其他要求。

This includes ensuring the software is validated and all necessary security measures are in place to prevent unauthorized access and data tampering, among other things.

这包括确保软件经过验证，并采取一切必要的安全措施，以防止未经授权的访问和数据篡改，以及其他方面的要求。

The software should also be periodically reviewed and updated to ensure it remains compliant with regulatory requirements.

还应定期审查和更新软件，以确保其符合监管要求。

Relevant requirements concerning a QMS system validation are the following:

与 QMS 系统验证相关的要求如下：

• FDA 21 CFR Part 11 FDA 21 CFR 第 11 部分
• EU GMP Annex 11 欧盟 GMP 附件 11
• ISPE GAMP5 ISPE GAMP5
• ISO 13485:2016 Clause 4.1.6 ISO 13485:2016 第 4.1.6 条款
• FDA 21 CFR Part 820.70(i) FDA 21 CFR 第 820.70（i）部分

FDA 21 CFR Part 11

The 21 CFR Part 11 regulates how electronic records are created, modified, maintained, and stored.

21 CFR 第 11 部分规定了电子记录的创建、修改、维护和存储方式。

It specifies the requirements to ensure the accuracy and security of electronic records, including the validation of open and closed systems.

它规定了确保电子记录准确性和安全性的要求，包括开放和封闭系统的验证。

This regulation also sets the guidelines for electronic signatures, which are legally binding and serve as an equivalent to traditional handwritten signatures.

该法规还制定了电子签名的指导方针，这些签名具有法律约束力，并可作为传统手写签名的等效物。

You can read our article on the 21 CFR Part 11 requirements to learn more about this regulation.

您可以阅读我们关于 21 CFR 第 11 部分要求的文章，以了解更多关于这项法规的信息。

EU GMP Annex 11

The EU GMP Annex 11 provides Good Manufacturing Practices (GMP) guidelines for computerized systems.

欧盟 GMP 附录 11 为计算机系统提供了良好的生产规范（GMP）指南。

It specifies the requirements to ensure computer systems do not cause a reduction in product quality, process control, or quality assurance, nor increase the overall risk of the process.

它规定了确保计算机系统不会降低产品质量、过程控制或质量保证，也不会增加整个过程的风险的要求。

The validation documentation must contain change control records and reports on any deviations detected during the validation process.

验证文件必须包含变更控制记录和在验证过程中检测到的任何偏差的报告。

Having an updated inventory of all relevant systems and their GMP functionality is also important.

更新所有相关系统及其 GMP 功能的清单也很重要。

ISPE GAMP5

The Good Automated Manufacturing Practice 5 (GAMP5) is a guideline developed by the International Society for Pharmaceutical Engineering (ISPE) for computerized systems.

GAMP5 是由国际制药工程学会（ISPE）制定的计算机系统指南。

It provides a risk-based approach to the validation and maintenance of computerized systems to ensure their accuracy, reliability, and consistency.

它提供了一种基于风险的方法来验证和维护计算机系统，以确保其准确性，可靠性和一致性。

SimplerQMS software is fully validated according to ISPE GAMP5. It is re-validated upon creating a new version or applying standard updates. This helps you to save time to focus on more value-added activities.

SimplerQMS 软件完全符合 ISPE GAMP5 的要求。在创建新版本或应用标准更新时，它会重新验证。这有助于您节省时间，专注于更有价值的活动。

Our solution also complies with FDA 21 CFR Part 11 and EU GMP Annex 11 for electronic records, electronic signatures, and computerized system manufacturing guidelines.

我们的解决方案还符合 FDA 21 CFR 第 11 部分和欧盟 GMP 附录 11 的电子记录，电子签名和计算机系统制造指南。

ISO 13485:2016 Clause 4.1.6

Clause 4.1.6 in the ISO 13485:2016 establishes that the medical device manufacturer must document procedures for validating computer software used in the QMS before initial use and after any changes to the software.

ISO 13485:2016 中的 4.1.6 条款规定，医疗器械制造商必须在首次使用计算机软件之前和软件发生任何变化之后，记录验证质量管理体系中使用的计算机软件的程序。

The specific approach and activities for software validation and revalidation should correspond to the risk associated with its use.

软件验证和重新验证的具体方法和活动应与其使用风险相对应。

FDA 21 CFR Part 820.70(i)

The 21 CFR Part 820 section 70(i) also specifies that manufacturers must validate computer software for its intended use according to an established protocol.

第 21 CFR 第 820 节第 70(i)条还规定，制造商必须根据既定协议验证计算机软件的预期用途。

All software changes must be validated before approval and issuance, documenting all validation activities and results.

所有软件更改必须在批准和发布之前进行验证，记录所有验证活动和结果。

Major Medical Device QMS Processes 医疗器械 QMS 的主要流程

We will focus only on some of the major medical device QMS processes in accordance with international standards and regulations – the ISO 13485:2016 standard and the FDA 21 CFR Part 820 regulation.

我们将仅关注符合国际标准和法规 — ISO 13485:2016 标准和 FDA 21 CFR Part 820 法规的一些主要医疗器械 QMS 流程。

Among several QMS processes, some of them are mentioned in both ISO 13485:2016 and FDA 21 CFR Part 820. This section will briefly discuss only some of these quality processes and their requirements.

在几个 QMS 流程中，其中一些在 ISO 13485:2016 和 FDA 21 CFR Part 820 中都有提及。本节将简要讨论其中一些质量流程及其要求。

Note

Please note that many more standards, guidelines, and regulations may apply to your business. Always refer to the applicable requirements for official information.

请注意，您的业务可能适用更多的标准、指南和法规。始终参考适用要求以获取官方信息。

According to these, the major medical device quality management requirements can be summarized as given in the following subsections:

根据这些要求，主要的医疗器械质量管理要求可以总结如下：

• Document Control 文件控制
• Training Management 培训管理
• Audit Management 审计管理
• CAPA Management 纠正预防措施管理

Document Control 文档控制

Your medical device quality management system should include processes and procedures for managing the many different documents that move within your company, amongst sponsors, investors, and regulatory agencies throughout the lifecycle of your product.

您的医疗设备质量管理体系应包括处理在公司内部、赞助商、投资者和监管机构之间流动的许多不同文档的流程和程序，以贯穿产品的整个生命周期。

This entire process is referred to as document control.

这整个过程被称为文档控制。

Over the past decade, many manufacturers have migrated from traditional paper-based QMS to automated medical device quality management software with robust document control capabilities.

在过去的十年中，许多制造商已经从传统的纸质 QMS 迁移到具有强大文档控制功能的自动化医疗设备质量管理软件。

Such software automatically collects data, routes documents for review and approval processes of various documents, and stores them in a single storage location.

这种软件自动收集数据，将各种文件路由到审查和批准流程中，并将它们存储在一个单一的存储位置中。

QMS software, such as SimplerQMS, provides automatic version control, which ensures that only the latest version of the documents is in circulation.

QMS 软件，如 SimplerQMS，提供自动版本控制，确保只有最新版本的文件在流通中。

SimplerQMS offers pre-configured workflows to simplify document control. You can easily create documents using forms or document templates and route them for review as often as needed. After the final version of a document is approved and released, employees are automatically notified.

SimplerQMS 提供预配置的工作流程，以简化文档控制。您可以使用表单或文档模板轻松创建文档，并根据需要将其路由进行审查。在文档的最终版本获得批准和发布后，员工会自动收到通知。

Moreover, if you want to know more about document control, read our articles on Quality Management System Documentation and Medical Device Document Control.

Training Management 培训管理

International regulations and standards such as the FDA 21 CFR 820 and ISO 13485:2016 require medical device manufacturers to have specifically trained and competent employees doing their job.

国际法规和标准，如 FDA 21 CFR 820 和 ISO 13485:2016 要求医疗器械制造商必须有经过专门培训和胜任的员工来完成他们的工作。

This means that all training procedures must be constantly evaluated, and all employee training records must be appropriately maintained.

这意味着所有培训程序必须不断评估，并且必须适当地维护所有员工培训记录。

For instance, changes to the manufacturing process of medical devices must be learned by all personnel involved. This means companies must provide training and assess the training effectiveness to ensure employees have the skill to perform their duties.

例如，所有涉及的人员都必须学习医疗设备制造过程的变化。这意味着公司必须提供培训并评估培训效果，以确保员工具备履行职责所需的技能。

SimplerQMS provides training management software to help streamline the entire training process. From assigning training tasks to specific employees, distributing training material, and tracking all training activities, to providing quizzes to measure training effectiveness.

SimplerQMS 提供培训管理软件，以帮助简化整个培训过程。从分配培训任务给特定员工，分发培训材料和跟踪所有培训活动，到提供测验以衡量培训效果。

Audit Management 审计管理

The FDA 21 CFR 820 and ISO 13485:2016 require medical device manufacturers to establish a proper audit process and conduct regular quality audits.

FDA 21 CFR 820 和 ISO 13485:2016 要求医疗器械制造商建立适当的审计流程并进行定期质量审计。

This is to ensure that the medical device quality management system as a whole is compliant.

这是为了确保整个医疗器械质量管理体系符合要求。

Companies need to properly audit all the applicable requirements for a medical device to ensure compliance regarding product safety and efficacy.

公司需要适当审计医疗器械的所有适用要求，以确保产品的安全性和功效符合要求。

The audit management module by SimplerQMS facilitates the entire audit process. You can schedule activities, set due dates, send automatic notifications to the right personnel, and track employee performance related to their assignments.

SimplerQMS 的审计管理模块简化了整个审计流程。您可以安排活动，设置截止日期，向相关人员发送自动通知，并跟踪员工在任务方面的表现。

Whenever an audit finding occurs, you will be able to easily link it to a nonconformance case, supplier corrective action request (SCAR), or escalate to corrective action and preventive action (CAPA).

每当发现审计结果时，您可以轻松将其与不符合案例、供应商纠正措施请求（SCAR）关联，或升级为纠正措施和预防措施（CAPA）。

You can read our article on medical device audits to learn more about the different audits in the medical device industry.

您可以阅读我们关于医疗器械审计的文章，以了解医疗器械行业中的不同审计。

CAPA Management

As per the FDA 21 CFR 820 and the ISO 13485:2016 requirements, all manufacturers of medical devices must implement the process of managing corrective actions and preventive actions (CAPA).

根据 FDA 21 CFR 820 和 ISO 13485:2016 的要求，所有医疗器械制造商必须实施管理纠正措施和预防措施（CAPA）的过程。

The CAPA process is essential to resolve and prevent issues that are likely to impact the quality of the product, such as nonconformances, audit findings, complaints, etc. Additionally, all actions must be documented adequately and resolved in a timely manner.

CAPA 过程对于解决和预防可能影响产品质量的问题（如不符合项、审计结果、投诉等）至关重要。此外，所有行动必须得到充分记录，并及时解决。

Key CAPA process steps are illustrated below.

下面是关键的 CAPA 过程步骤的示意图。

With the SimplerQMS CAPA management software, you can streamline the entire CAPA process by automating data collection, routing, follow-ups, notifications, approvals, and escalation of overdue activities.

使用 SimplerQMS CAPA 管理软件，您可以通过自动化数据收集、路由、跟进、通知、批准和逾期活动的升级，简化整个 CAPA 流程。

You can quickly initiate CAPA forms directly from issues, such as nonconformances or deviations, audit findings, and customer complaints.

您可以直接从问题（如不符合项或偏差、审计结果和客户投诉）中快速启动 CAPA 表单。

The system automatically enters data from the metadata in the CAPA form to reduce human error. It also enables you to relate documents in scope and eliminates the need to circulate documents or chase signatures manually.

系统会自动从 CAPA 表单中的元数据输入数据，以减少人为错误。它还可以让您关联范围内的文档，并消除了手动传递文档或追踪签名的需要。

Check out our article to better understand what CAPA is in the medical device industry.

查看我们的文章，以更好地了解医疗设备行业中的 CAPA 是什么。

In addition to the quality processes mentioned in this section, several other processes are required as per standards and regulations, such as ISO 13485:2016 and FDA 21 CFR Part 820.

除了本节中提到的质量流程外，还需要根据标准和法规执行其他几个流程，如 ISO 13485:2016 和 FDA 21 CFR Part 820。

Some of these include:

其中一些包括：

• Change management 变更管理
• Complaint management 投诉管理
• Nonconformance management 不符合管理
• Equipment management 设备管理
• Supplier management 供应商管理

This article does not cover all sections above. Companies should always verify which processes are relevant to them and comply with the specific requirements that apply to their business.

本文不涵盖上述所有部分。公司应始终核实哪些流程与其相关，并遵守适用于其业务的具体要求。

Role of Medical Device Quality Management Software 医疗器械质量管理软件的作用

A medical device quality management system is essential for ensuring products are safe and effective for their intended use.

医疗器械质量管理系统对于确保产品在其预期使用中的安全性和有效性至关重要。

It is a requirement of many standards and regulations that medical device companies have a compliant QMS.

许多标准和法规要求医疗器械公司拥有符合要求的质量管理体系。

Companies can have a paper-based or hybrid QMS by implementing a manual system. The latter approach may be adequate for small companies with adequate resources, but it can be time-consuming, prone to errors, and challenging to maintain compliance with regulatory requirements.

公司可以通过实施手动系统来拥有基于纸质或混合的质量管理体系。后一种方法对于资源充足的小公司可能是足够的，但它可能耗时、容易出错，并且难以满足监管要求。

Electronic QMS provides an alternative solution that offers greater efficiency and accuracy, making it a robust option for numerous companies.

电子 QMS 提供了一种替代方案，提供了更高的效率和准确性，使其成为众多公司的强大选择。

Medical device manufacturers can use such software to manage quality processes throughout the product lifecycle, from design and development to manufacturing, labeling, distribution, and corrective and preventive actions.

医疗器械制造商可以使用这种软件来管理产品生命周期中的质量流程，从设计和开发到制造、标签、分销以及纠正和预防措施。

The benefits of medical device quality system software include the following:

医疗器械质量体系软件的好处包括以下几点：

• Ensure compliance with regulatory requirements using pre-configured workflows. 使用预配置的工作流确保符合监管要求
• Improve customer satisfaction by addressing issues in a timely manner. 通过及时解决问题提高客户满意度
• Save time with automated documentation processes. 通过自动化文档流程节省时间
• Ensure traceability with automated data collection and flexible linking capabilities. 通过自动化数据收集和灵活的链接能力确保可追溯性
• Improve communication and collaboration across departments. 改善部门间的沟通和协作
• Reduce the risk of inaccuracies by mitigating human errors associated with manual data entry. 通过减少与手动数据输入相关的人为错误降低不准确性的风险

SimplerQMS provides an eQMS designed for the medical device industry. Our software streamlines quality processes and helps companies in achieving compliance with regulatory requirements.

SimplerQMS 为医疗设备行业提供了一种设计精良的电子质量管理系统（eQMS）。我们的软件简化了质量流程，并帮助公司达到法规要求的合规性。

We offer robust document management capabilities that simplify document creation, versioning, review, approval, and search within one secure location.

我们提供强大的文档管理功能，可以在一个安全的位置内简化文档的创建、版本控制、审查、批准和搜索。

Our QMS modules are interconnected and allow for easy linking of complaints, CAPAs, training, and other quality management processes.

我们的 QMS 模块相互连接，可以方便地链接投诉、CAPA、培训和其他质量管理流程。

The SimplerQMS system is fully validated in compliance with ISPE GAMP5 and undergoes revalidation for each new version or standard update.

SimplerQMS 系统完全符合 ISPE GAMP5 的要求，并在每个新版本或标准更新时进行重新验证。

It also complies with FDA 21 CFR Part 11, which sets the guidelines for electronic signatures and electronic records, and EU GMP Annex 11, which provides good manufacturing guidelines for computerized systems.

它还符合 FDA 21 CFR 第 11 部分的规定，该部分规定了电子签名和电子记录的指南，以及欧盟 GMP 附件 11，该附件为计算机化系统提供了良好的制造指南。

Now that you are aware of the benefits of an eQMS in terms of compliance and streamlined workflows, it is important to consider the associated time and cost savings.

现在您已经了解了 eQMS 在合规性和流程优化方面的好处，重要的是要考虑相关的时间和成本节约。

Understanding these factors will help you make an informed decision about whether to allocate a budget for an eQMS and move forward with implementation.

了解这些因素将帮助您对是否为 eQMS 分配预算并继续实施做出明智的决策。

We recommend downloading our eQMS Business Case template. This tool will help you provide decision-makers with concrete evidence of the benefits of implementing an eQMS and make a compelling case for the investment.

我们建议下载我们的 eQMS 商业案例模板。这个工具将帮助您向决策者提供实施 eQMS 的好处的具体证据，并为投资提供有力的论据。

Frequently Asked Questions (FAQs) About Medical Device QMS 关于医疗器械质量管理体系（QMS）的常见问题（FAQ）

What Are the Two Main Quality Systems Adopted by Medical Device Manufacturers? 什么是医疗器械制造商采用的两个主要质量体系

The two main quality systems medical device manufacturers adopt are the FDA 21 CFR 820 and the ISO 13485:2016.

医疗器械制造商采用的两个主要质量体系是 FDA 21 CFR 820 和 ISO 13485:2016。

The FDA 21 CFR 820 sets the requirements for quality management systems in the US, while ISO 13485:2016 is an international regulatory standard that outlines the requirements for QMS for medical devices in the EU and other countries.

FDA 21 CFR 820 规定了美国质量管理体系的要求，而 ISO 13485:2016 是一个国际监管标准，概述了欧盟和其他国家医疗器械质量管理体系的要求。

What is the Best Quality Management Software for Medical Devices? 什么是医疗器械的最佳质量管理软件？

The best medical device QMS software for your company will depend on various factors, such as the size and complexity of your company, applicable specific requirements, available time, and budget.

对于您的公司来说，最好的医疗器械质量管理软件将取决于各种因素，如公司的规模和复杂性，适用的特定要求，可用的时间和预算。

QMS software solutions are available for Life Science companies in the medical device, pharmaceutical, biotechnological, and other industries. Each solution has unique features and qualities, so it is essential to consider your company’s specific needs and regulatory requirements.

医疗器械行业的生命科学公司可以使用 QMS 软件解决方案，包括医疗器械、制药、生物技术和其他行业。每个解决方案都具有独特的功能和特点，因此必须考虑公司的特定需求和监管要求。

The chosen software should be easy to use and provide good customer support to help with any doubts or problems that may arise. For a more straightforward evaluation, there is a compiled list of the 6 best QMS software solutions for Life Sciences options available.

选择的软件应该易于使用，并提供良好的客户支持，以帮助解决可能出现的任何疑问或问题。为了更直接地评估，这里有一个编制的列表，列出了 6 个最佳的生命科学质量管理软件解决方案可供选择。

Additionally, our QMS software comparison template can be used to compare shortlisted options and select the best one for your company or as a reference to develop a list of requirements for quality management software.

此外，我们的质量管理软件比较模板可用于比较入围选项，并选择最适合您公司的最佳选项，或作为开发质量管理软件需求清单的参考。

What Is the ISO 13485:2016 Quality Management System? 什么是 ISO 13485:2016 质量管理体系？

The ISO 13485:2016 QMS standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements.

ISO 13485:2016 QMS 标准规定了一个质量管理体系的要求，组织需要展示其能够提供符合客户和适用法规要求的医疗设备和相关服务。

You can learn more about this international regulatory standard in our article on ISO 13485:2016 Compliant QMS.

您可以在我们的 ISO 13485:2016 合规 QMS 文章中了解更多关于这个国际法规标准的信息。

When Is a Quality Management System (QMS) Required for Medical Devices? 何时需要医疗器械质量管理体系（QMS）？

Medical device companies require a Quality Management System (QMS) when registering devices for marketing and selling.

医疗器械公司在注册设备进行市场销售时需要质量管理体系（QMS）。

Compliance with FDA 21 CFR Part 820 is required for operating in the US market, and medium to high-risk devices must go through the 510(K) process.

在美国市场运营需要符合 FDA 21 CFR 第 820 部分的规定，中高风险设备必须经过 510(K) 流程。

In Europe, obtaining the CE marking is required for marketing and selling devices, and certification to ISO 13485:2016 can be used to comply with the QMS requirements of the MDR or IVDR.

在欧洲，需要获得 CE 标志以进行设备的市场销售，并且可以通过 ISO 13485:2016 认证来符合 MDR 或 IVDR 的 QMS 要求。

When Should I Start Building a Medical Device QMS? 何时应该开始建立医疗器械质量管理体系？

Timing is crucial when building a QMS.

在建立质量管理体系时，时间非常关键。

Starting the QMS during the early prototype phase or idea testing can put unnecessary constraints on development. Sufficient research and knowledge should be obtained before building the QMS.

在早期原型阶段或者想法测试阶段开始建立质量管理体系可能会对开发造成不必要的限制。在建立质量管理体系之前，应该获得足够的研究和知识。

However, it is also not advisable to wait too long to build the QMS, as it takes time to develop a suitable system.

然而，等待太久来建立质量管理体系也是不可取的，因为开发一个合适的系统需要时间。

The ideal time to start building a medical device QMS is when enough information and knowledge have been gathered to ensure an efficient QMS development process. This can be around the Design and Development phase.

开始建立医疗器械质量管理体系的理想时间是在收集到足够的信息和知识以确保高效的质量管理体系开发过程时。这可能是在设计和开发阶段左右。

How Long Does It Take to Fully Implement Medical Device QMS? 完全实施医疗器械质量管理体系需要多长时间？

It typically takes 3 to 9 months to fully establish a medical device QMS. Still, medical device consultants suggest starting preparations at least 18-24 months before commercialization.

通常需要 3 到 9 个月才能完全建立医疗器械质量管理体系。然而，医疗器械顾问建议至少在商业化前的 18-24 个月开始准备。

Using a document template for processes and protocols is advantageous and can help speed up the implementation.

使用流程和协议的文件模板是有优势的，可以帮助加快实施进程。

SimplerQMS offers a customizable document template package based on Life Science requirements, such as ISO 13485:2016, to simplify the creation of documents and streamline your quality documentation processes by managing forms and templates effectively.

SimplerQMS 提供了一个基于生命科学要求（如 ISO 13485:2016）的可定制的文件模板包，以简化文件的创建，并通过有效管理表格和模板来简化您的质量文件流程。

Conclusion 总结

The medical device quality management system is a regulatory requirement for manufacturers of medical devices. The quality management system covers all aspects of the medical device’s lifecycle.

医疗器械质量管理体系是医疗器械制造商的法规要求。质量管理体系涵盖了医疗器械生命周期的所有方面。

It is a regulated framework comprising strategies and procedures for the design, clinical data, manufacturing, storage and distribution, supplier management, complaints, labeling, and other aspects of your medical devices.

它是一个受监管的框架，包括设计、临床数据、制造、储存和分销、供应商管理、投诉、标签和其他医疗器械方面的策略和程序。

SimplerQMS medical device QMS software streamlines your quality management processes by managing routine documentation tasks, enabling you to achieve greater efficiency while making compliance easier.

SimplerQMS 医疗器械质量管理软件通过管理例行文件任务来简化您的质量管理流程，使您能够在提高效率的同时更容易遵守规定。

If you are looking for a comprehensive QMS software solution to manage quality processes more effectively, schedule a demo presentation to see SimplerQMS in action and talk to our experts.

如果您正在寻找一种全面的质量管理软件解决方案，以更有效地管理质量流程，请安排一个演示展示，了解 SimplerQMS 的功能并与我们的专家交流。

References 参考文献

• Medical Device Quality Management System (QMS) - SimplerQMS