医疗器械设计开发

Design Controls indicate that the medical devices your company makes are both safe and efficacious for the end-users.

设计控制表明，贵公司生产的医疗设备对最终用户来说既安全又有效。

Let us say that your R&D department has come with a brilliant idea for a knee implant that will eliminate the disadvantages of currently available models. Now, you need to assure international regulatory agencies that your medical device will serve its purpose, is safe and efficacious before you market it.

假设你的研发部门提出了一个关于膝关节植入物的绝妙想法，可以消除目前可用模型的缺点。现在，你需要向国际监管机构保证你的医疗设备在上市之前能够发挥作用，安全有效。

This is the crux of Design Controls.

这就是设计控制的关键。

You are proving to the concerned authorities that the knee implant your company has designed is a safe product that will meet all the needs and prerequisites of the end-user.

你正在向相关部门证明，贵公司设计的膝关节植入物是一种安全的产品，能够满足最终用户的所有需求和前提条件。

What are Design Controls? 设计控制是什么？

Regulatory agencies across the globe want assurances that the medical devices your company produces are safe and efficacious. You must be able to prove that your medical devices meet end-user needs and requirements. As mentioned before, this is the essence of Design Controls.

全球各地的监管机构希望确保贵公司生产的医疗设备安全有效。您必须能够证明您的医疗设备满足最终用户的需求和要求。正如之前提到的，这就是设计控制的本质。

Let us revisit the knee implant designed by your company. You now need to prove to regulatory agencies that it will serve its purpose, is safe and efficacious through Design Controls.

让我们重新审视一下贵公司设计的膝关节植入物。您现在需要通过设计控制向监管机构证明它将发挥作用，是安全和有效的。

Do You Need to Develop Your Product Under Design Controls? 你需要在设计控制下开发产品吗？

First of all, you will need to check whether your planned medical device needs Design Controls.

首先，您需要检查您计划的医疗设备是否需要设计控制。

All Class II and Class III medical devices need to be brought under Design Controls. This means that X-ray machines, surgical needles, implantable medical devices (for instance, your planned knee implant) are amongst the medical devices that come under Design Controls.

所有 II 类和 III 类医疗设备都需要纳入设计控制。这意味着 X 射线机、手术针、可植入医疗设备（例如，您计划的膝关节植入物）都属于纳入设计控制的医疗设备之列。

We know that 47% of all medical devices come under Class I. These are low-risk products that include:

我们知道，所有医疗设备中有 47% 属于一类。这些是低风险产品，包括：

Bedpans 便盆
Crutches 拐杖
Canes 手杖
Bandages 绷带
Braces 支架
Etc. 等等

Most of these devices are exempt from Design Controls.

这些设备中的大部分都不受设计控制的限制。

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

推荐阅读：医疗器械分类指南（FDA 和欧盟 MDR）

In case you doubt whether your medical device comes under Design Controls, you should contact a medical device consultant who will go through the requirements that apply to your particular situation.

如果你怀疑你的医疗器械是否受到设计控制的限制，你应该联系一位医疗器械顾问，他将会了解适用于你特定情况的要求。

What Are the Standards and Regulations Governing Design Controls? 什么是管理设计控制的标准和规定？

Some of the applicable regulations and standards that govern Design Controls are:

一些适用的管理设计控制的规定和标准包括：

FDA 21 CFR Part 820.30

Design Controls is a term defined by the FDA 21 CFR 820.30.

设计控制是由 FDA 21 CFR 820.30 定义的一个术语。

These are a set of regulations that the FDA has set out for current good manufacturing practices (cGMP) to be followed by medical device manufacturers in the United States.

这些是 FDA 为美国医疗器械制造商制定的遵循当前良好制造规范（cGMP）的一套规定。

ISO 13485:2016

The ISO 13485:2016 standard specifies requirements for a quality management system (QMS) when a medical device manufacturer needs to demonstrate their ability to provide medical devices and related services that will meet customer and applicable regulatory requirements.

ISO 13485:2016 标准规定了医疗器械制造商在需要证明其能够提供符合客户和适用法规要求的医疗器械和相关服务时，质量管理体系（QMS）的要求。

The following table compares the relevant clauses under the FDA 21 CFR 820.30 to ones under the ISO 13485:2016.

下表将 FDA 21 CFR 820.30 下的相关条款与 ISO 13485:2016 下的条款进行了比较。

Design Control — FDA 21 CFR Part 820.30	Design & Development — ISO 13485:2016
a) General	7.3.1 General
b) Design and development planning	7.3.2 Design and development planning
c) Design input	7.3.3 Design and development inputs
d) Design output	7.3.4 Design and development outputs
e) Design review	7.3.5 Design and development review
f) Design verification	7.3.6 Design and development verfication
g) Design validation	7.3.7 Design and development validation
h) Design transfer	7.3.8 Design and development transfer
i) Design changes	7.3.9 Design and development changes
j) Design history file	7.3.10 Design and development files

As you can see from the table, the relevant subsections of FDA 820.30 such as (a) General, (b) Design and development planning, etc. have comparable subsections under ISO 13485:2016.

从表中可以看出，FDA 820.30 的相关子节，如 (a) 总则，(b) 设计和开发计划等，在 ISO 13485:2016 下有相应的子节。

This also means that you will have to maintain a lot many documents and records about a single medical device.

这也意味着您将需要维护许多关于单个医疗设备的文件和记录。

Additionally, you might be faced with the challenges of getting the signatures of the requisite staff, tracking all these documents circulating between various departments of your organization. To avoid all these hassles, nowadays medical device manufacturers prefer QMS software, designed for medical device companies.

此外，您可能面临着获取必要人员的签名，跟踪所有这些文件在您组织的各个部门之间流转的挑战。为了避免所有这些麻烦，现在医疗设备制造商更喜欢为医疗设备公司设计的 QMS 软件。

What Are the Different Design Control Phases?

Let’s imagine that you have determined that the new knee implant you are planning to bring to the market needs Design Controls.

让我们想象一下，您已经确定您计划推向市场的新膝关节植入物需要设计控制。

So, let us, now, look at the nitty-gritty of the design control process.

所以，现在让我们来看看设计控制过程的细节。

The 9 different design control phases are the following.

9 个不同的设计控制阶段如下。

1. User Needs Phase 用户需求阶段

The user needs phase is the first step of designs control. Your team will need to identify and establish the intended use and indications for use of the proposed medical device.

用户需求阶段是设计控制的第一步。您的团队需要确定和建立拟议医疗设备的预期使用和使用指示。

The intended use of the new medical device is the objective. This means the general purpose of the device.

新医疗设备的预期用途是客观的。这意味着设备的一般目的。

On the other hand, indications for use should describe the disease and/or the conditions that the proposed medical device will diagnose, prevent, cure, or mitigate.

另一方面，使用指示应描述拟议医疗设备将诊断、预防、治愈或缓解的疾病和/或条件。

During this phase, you will also need to define the potential patient population for which your medical device is indicated.

在此阶段，您还需要定义适用于您的医疗设备的潜在患者人群。

2. Design and Development Planning Phase 设计和开发规划阶段

The next step in Design Controls is the design and development planning phase.

设计控制的下一步是设计和开发规划阶段。

To start this process of Design Controls, your team will have to establish a plan that will illustrate design and development activities, highlight the responsibilities for implementing the plan, and include the protocols for reviewing, documenting, updating, and approving plans as this phase progresses.

为了开始设计控制的这个过程，您的团队将需要制定一个计划，该计划将说明设计和开发活动，突出实施计划的责任，并包括审核、文档化、更新和批准计划的协议，随着这个阶段的进行。

Let us look at what the regulatory authorities state about this design control phase.

让我们看看监管机构对这个设计控制阶段的规定。

The FDA 21 CFR 820.30 defines the Design and Development Planning phase in subsection (b) as the following:

FDA 21 CFR 820.30 在第(b)小节中定义了设计和开发规划阶段如下：

“Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.”

“每个制造商都应建立和维护描述或参考设计和开发活动并定义实施责任的计划。这些计划应识别和描述与提供或导致设计和开发过程输入的不同组或活动的接口。”

The ISO 13485:2016 7.3.2 defines the Design and Development Planning phase as the following:

ISO 13485:2016 7.3.2 将设计和开发规划阶段定义如下：

“The organization shall plan and control the design and development of a product. As appropriate, design and development planning documents shall be maintained and updated as the design and development progresses.”

“组织应计划和控制产品的设计和开发。根据需要，设计和开发规划文件应在设计和开发进展中进行维护和更新。”

3. Design Input Phase 设计输入阶段

During this phase of Design Controls, your team will need to describe the exact specifications of your proposed medical device. You will need to emphasize what the device will do and how it will perform.

在设计控制的这个阶段，您的团队需要描述您提议的医疗设备的确切规格。您需要强调设备将会做什么以及如何执行。

Let us look at the new knee implant that your company is planning to manufacture. The intended use is to restore function in severely diseased knee joints and mitigate the pain. Its performance should be superior to the currently available products in the market.

让我们来看看您的公司计划制造的新膝关节植入物。其预期用途是恢复严重疾病的膝关节功能并减轻疼痛。其性能应优于市场上当前可用的产品。

4. Design Output Phase 设计输出阶段

During this phase of Design Controls, your team will document the exact specifications of the new medical device.

在设计控制的这个阶段，您的团队将记录新医疗设备的确切规格。

What are the intended materials and components needed to build the new device?

构建新设备所需的材料和组件是什么？

Questions like the one above are answered during the design output phase.

像上面的问题在设计输出阶段得到了回答。

As you develop design outputs, you will need to show their relationship to design inputs (Phase 3) with a Design Controls Traceability Matrix. The relationships between Design Inputs and Design Outputs can be done in Microsoft Excel. This is possible at the beginning of the product development phase. However, do remember that later, this can become rather complex.

在开发设计输出时，您需要展示它们与设计输入（第三阶段）的关系，使用设计控制可追溯性矩阵。设计输入和设计输出之间的关

Another point to be remembered during the Design Output Phase is that you should establish the Device Master Record (DMR).

在设计输出阶段需要记住的另一点是，您应该建立设备主记录（DMR）。

The DMR will contain all the information and specifications that you need to manufacture a medical device from start to finish. It will also include instructions for the complete manufacturing processes, drawings, specifications, and labeling and packaging requirements.

DMR 将包含您从头到尾制造医疗设备所需的所有信息和规格。它还将包括完整制造过程的说明、图纸、规格以及标签和包装要求。

5. Design Review Phase 设计评审阶段

During the process of Design Controls, your team will need to conduct formal design reviews and validate them. During these stages of Design Review, you will get the opportunity to evaluate the design requirements of your new medical device. You will be able to ensure that your device is on track.

在设计控制的过程中，您的团队将需要进行正式的设计评审并对其进行验证。在这些设计审查阶段，您将有机会评估新医疗设备的设计要求。您将能够确保您的设备正处于正确的轨道上。

Let us look at the example of your novel knee implant. With a variety of experts on board, you will ensure that all specifications are met and there are no glitches.

让我们来看看您的新型膝关节植入物的例子。有各种专家参与，您将确保所有规格都得到满足，没有任何故障。

6. Design Verification Phase 设计验证阶段

During this phase of Design Controls, your team will test the new medical device in a variety of ways to make sure that it has been developed properly.

在设计控制的这个阶段，您的团队将以各种方式测试新的医疗设备，以确保其已经正确开发。

To put it succinctly, you are ensuring that your medical device is working as intended.

简而言之，您正在确保您的医疗设备按预期工作。

Taking the example of the novel knee implant, you are ensuring during this phase that it is actually doing its job!

以新型膝关节植入物为例，您在这个阶段确保它实际上在发挥作用！

7. Design Validation Phase 设计确认阶段

This phase means that your medical device conforms to the needs of the user and its intended use. Design validation is performed using initial production units, batches, or lots, and not on prototypes.

这个阶段意味着您的医疗设备符合用户的需求和预期使用。设计确认是使用初始生产单位、批次或批量进行的，而不是使用原型。

The question “Did we develop the correct device?” is answered during this phase.

在这个阶段回答了“我们是否开发了正确的设备？”这个问题。

8. Design Transfer Phase 设计转移阶段

During this phase of Design Controls, you will actually start the production of your medical device.

在设计控制的这个阶段，您将实际开始生产医疗设备。

You must ensure that the complete details of the design are transferred correctly to the production team so that the medical device is manufactured without any hindrances or obstacles.

您必须确保设计的完整细节正确地转移到生产团队，以便医疗设备能够无障碍地制造。

Looking at the example of the new knee implant, you will ensure that during the design transfer phase, the product is manufactured according to specifications.

以新的膝关节植入物为例，您将确保在设计转移阶段，产品按照规格制造。

9. Design Changes Phase 设计变更阶段

If there are any revisions to the original design of a medical device, the Design Changes Phase comes into play.

如果对医疗设备的原始设计进行了任何修改，就会进入设计变更阶段。

Let’s say that you need to make some adjustments in the manufacture of your novel knee implant. This is possible through proper document control and change control during the Design Changes Phase.

假设您需要对新型膝关节植入物的制造进行一些调整。通过适当的文件控制和变更控制，可以在设计变更阶段实现这一点。

It might be that you are struggling with the management of your existing document control and change control tasks. QMS software with built-in document control and change control capabilities can help you to automate reoccurring tasks such as data collection, routing, follow-ups, notifications, approvals, and much more. This basically means that all change control of documents and product changes can be managed with an integrated Quality Management System (QMS) software solution.

也许您正在为现有的文件控制和变更控制任务的管理而苦恼。具有内置文件控制和变更控制功能的 QMS 软件可以帮助您自动化重复性任务，如数据收集、路由、跟进、通知、批准等等。这基本上意味着所有文档和产品变更的变更控制可以通过集成的质量管理系统（QMS）软件解决方案来管理。

What is Design History File (DHF)? 什么是设计历史文件（DHF）？

All documentation about Design Controls should be compiled in a master file labeled as Design History File (DHF).

所有与设计控制有关的文件都应编制成一个标记为设计历史文件（DHF）的主文件。

The Design History File (DHF) will not only show all steps taken during the development of your new medical device but also detail the links between the various phases of Design Controls. This is a mandatory requirement for regulatory agencies (such as FDA 21 CFR 820 and ISO 13485:2016) worldwide.

设计历史文件（DHF）不仅会显示您的新医疗设备开发过程中所采取的所有步骤，还会详细说明设计控制各个阶段之间的联系。这是全球监管机构（如 FDA 21 CFR 820 和 ISO 13485:2016）的强制要求。

The creation of the DHF is typically the last step or phase in the Design Control process.

DHF 的创建通常是设计控制过程中的最后一步或阶段。

When you have efficient and reliable eQMS software such as SimplerQMS, you will find it much simpler to compile your DHF and to have it ready for audits and inspections.

当您拥有高效可靠的 eQMS 软件，如 SimplerQMS 时，您会发现编制 DHF 并准备好进行审计和检查变得更加简单。

Let us look at one such utility of the SimplerQMS design control software module, namely, the Document Collection feature. With such a solution, you can easily make a ‘snapshot’ of all current documentation for every product in your company. Subsequently, you will be able to export the required documentation or share it with relevant external agencies. This means that you will not have to waste any time searching for the required documentation when compiling your DHF, DMR, or TF.

让我们来看看 SimplerQMS 设计控制软件模块的一个实用功能，即文档收集功能。通过这样的解决方案，您可以轻松地为公司中的每个产品制作所有当前文档的“快照”。随后，您将能够导出所需的文档或与相关外部机构共享。这意味着在编制 DHF、DMR 或 TF 时，您将不必浪费时间搜索所需的文档。

How Does QMS Software Improve the Medical Device Design Control Process? QMS 软件如何改善医疗器械设计控制流程？

If your company is still reliant on manual paper-based systems for managing your DHF for every product in production, you would have realized that this is very time and labor-intensive and often leads to the following errors:

如果贵公司仍然依赖手动纸质系统来管理生产中每个产品的 DHF，您会意识到这非常耗时和劳动密集，并且经常导致以下错误：

Missing documents and records 缺少文件和记录
Missing signatures for document reviews and approvals 文件审查和批准的签名缺失
Disconnected processes and decreased traceability 流程断裂和追溯性降低
Other challenges… 其他挑战…

You can easily eliminate these problems by implementing QMS software at the very beginning of your product development cycle.

您可以在产品开发周期的最开始阶段通过实施 QMS 软件轻松解决这些问题。

Cloud-based Quality Management Software such as SimplerQMS is specifically designed to help organizations such as yours to accelerate market access by streamlining design control, and many other quality processes.

基于云的质量管理软件，如 SimplerQMS，专门设计用于帮助像贵组织一样的组织通过简化设计控制和许多其他质量流程来加快市场准入。

Frequently Asked Questions About Design Controls 关于设计控制的常见问题

What Is the Design Control Process? 什么是设计控制流程？

全球各地的监管机构希望确保贵公司生产的医疗设备安全有效。您必须能够证明您的医疗设备符合最终用户的需求和要求。这是设计控制的核心。

What Are Design Controls Used for? 设计控制用于什么？

设计控制旨在表明您公司的医疗设备安全、有效，并满足最终用户的要求。

Design Controls are intended to show that your company’s medical devices are safe, efficacious, and meet the requirements of the end-user.

What Are the Phases of Design Control? 设计控制的阶段有哪些？

The phases of Design Control are:

设计控制的阶段包括：

User Needs Phase 用户需求阶段
Design and Development Planning Phase 设计和开发计划阶段
Design Input Phase 设计输入阶段
Design Output Phase 设计输出阶段
Design Review Phase 设计审查阶段
Design Verification Phase 设计验证阶段
Design Validation Phase 设计确认阶段
Design Transfer Phase 设计转移阶段
Design Changes Phase 设计更改阶段
Design History File 设计历史文件

Conclusion 总结

Design Controls ensure that the medical device that your company is launching is safe, efficacious, and intended for its given purpose. International regulations and standards including FDA 21 CFR 820.30 and ISO 13485:2016 govern the different phases of Design Controls.

设计控制确保您的公司推出的医疗设备安全、有效，并且符合其预定目的。包括 FDA 21 CFR 820.30 和 ISO 13485:2016 在内的国际法规和标准管理设计控制的不同阶段。

With the use of cloud-based QMS software such as SimplerQMS, you can streamline design control and maintain quality throughout the lifecycle of all your medical devices. If you are interested in streamlining your design control processes using an integrated QMS software solution for medical devices, we recommend booking a demo to talk to our experts and see what SimpleQMS is capable of.

通过使用基于云的 QMS 软件，如 SimplerQMS，您可以简化设计控制并在所有医疗设备的生命周期内保持质量。如果您有兴趣使用集成的医疗设备 QMS 软件解决方案简化设计控制流程，我们建议预订演示，与我们的专家交流，并了解 SimpleQMS 的能力。