医疗器械项目测试协议的重要性

在规划任何测试项目时，您开发了一个测试协议是至关重要的。了解研究目标和方法将有助于确保成功的测试项目和减轻持续和未来的测试计划的风险。该协议应该明确了解对原因以及如何完成测试，必要的材料是什么，以及最重要的是，如何呈现和分析数据。yabo娱乐vip

我们经常被问到：“我需要一个测试协议吗？”或者“我如何发展一个？”本文档概述了协议的典型部分。在开始任何研究之前，我们强烈建议在开始测试协议，并将与您合作以开发您的测试策略。

为什么有测试计划如此关键？

无论您是在内部执行测试还是将其外包给可信合作伙伴，测试协议都用作捕获期望，验收标准，监管要求和适用标准的主要通信工具，并通过步骤来创建项目计划的步骤。它几乎就像地图。协议还根据将来的重复性作出相应地记录了此信息，并在使用修订控制中将团队保留在同一页面上。不可避免地，随着您从当前职位前进，将来有人会尝试复制您的学习或使用这些信息以备将来的测试目的。具有明确的协议有助于防止未来的不确定性与所做的事情，为什么它已经完成，以及如何进行。

How do you start?

测试协议有几个标准部分，并且根据您的监管策略，您可能希望根据需要包含所有这些或修改它们以与您的设计历史文件对齐。这些物品中的一些可能在其他文件中概述，并且在两个地方可能是多余的。典型的协议部分概述如下：

1. 范围
2. 目的
3. Reference Documents
4. 测试样品
5. yabo娱乐vip材料和设备
6. 方法
7. 验收标准
8. Exception Conditions
9. Data Analysis and Documentation Requirements
10. 参考

修订记录

适当的测试协议可能需要时间开发，并且应该在项目开头分配足够的资源。亚慱体育怎么下载通过项目进行追溯或中途的写作协议，因为您试图节省时间通常会导致测试报告中的延迟和不明确的期望。如果映射出正确的步骤，则可以轻松防止延迟，特别是如果您不经常执行测试。在我们的经验中，最成功的客户是在开始上识别起始监管需求和风险的客户，然后通过协议来减轻它而不是在飞行中执行它。

FDA发布了一个guidance document2019年12月20日，在预先临界工作台绩效测试信息中的推荐内容和格式，以预热的意见书，可能有助于审查。

范围, Background, and Purpose – What is the goal and why?

大多数协议从项目的范围或背景开始。它为设备奠定了基础，以及为什么正在评估它。目标或目的定义了输出。一个明确的目标设置项目的基调，并确定正在回答的问题或正在制定假设。下面列出了几个例子，以增加影响和清晰度：

1. To perform testing to evaluate the strength of the partial knee replacement.
2. To characterize the antero-posterior, medio-lateral, and rotational constraint behavior of a unicondylar knee replacement system.
3. 该测试涵盖了根据通过在体外环境中的特定负载条件下确定的固有关节设计的运动来定量单个狭窄膝关节置换约束。该测试表征了参考ASTM F1223的前后凹凸，Medio-横向剪切和旋转松弛。将结果与谓词相比进行比较。

Reference Documents

我们问一位新客户的第一个问题是，“你是否有一个测试标准，你正在寻找测试？”。通常答案是肯定的。如果不是，那么可能存在类似的标准以引用或偏离。本协议的这一部分应列出任何相关标准并评论任何预期的偏差。FDA指导文件也可以是参考，因为它们可能会概述所需的测试。

测试样品, Materials and Equipment

The Materials section should outline all of the components that are needed for testing, quantities, and any other relevant information. Maintaining traceability to ensure a clear expectation of what is to be tested is also essential.

An example table is shown below:

Another item that is helpful in the test samples section is the worst-case justification. For the medical device industry, it is critical to identify the worst-case configurations for testing. It is helpful to include this in the protocol along with any有限元分析结果，因为这通常是用户或未来的团队成员在选择特定设备大小的原因中唯一的洞察力。能够理解这些信息有助于快速识别问题或额外风险，并在项目的开头来解决它们。

The Materials section also contains the test equipment or apparatus that will be used. Identifying the load capacities and type of test frame can help ensure that the expected loads are within the calibrated ranges and minimize any equipment variability. General tuning parameters can also be included to reduce any risk. Fixtures and testing environments can be outlined, although they can also be listed in the Methods sections.

方法

The Methods or Procedure sections outline the actual testing steps. They often align with the applicable FDA guidance documents and ASTM or ISO testing specifications. If you are not sure how to get started with this section, the Procedures section in the standards is often the best place to go.

The Methods section should outline the test parameters for the testing project:

1. 样本准备 - 客户特定的装配说明
2. Test Configurations
3. 测试频率
4. Target Cycles
5. Target Load Data or Method for Load Selection
6. 测试环境
7. 测试率
8. 控制模式（力/位移）
9. R Ratios
10. Waveforms

此部分还应参考任何先前的研究或测试报告以确保可重复性。如果方法部分有几种不同的测试配置，则应为每个测试类型概述上面列出的参数。方法部分的一个关键区域是列出任何特定装配，拆卸或处理信息的轮廓。还应概述测试块或装载方向，拧紧扭矩和流体收集信息。

另一个关键块记录了任何自定义固定装置或设置指令。通常，包括测试设置或绘制夹具的示意图，以清楚清楚该设备的测试方式。在开发自定义测试方法时，这尤为重要。

验收标准和例外条件

定义数据，您正在寻找以及您正在比较的需要记录。根据先前或谓词测试确定接受标准，以帮助每个参与者评估正在生成的数据，并在需要时快速进行调整。它还驱动程序部分以确保与谓词的比较有“苹果”比较。如果您的设备没有可用的谓词，则验收标准的明确定义是至关重要的。还应注意到测试协议的任何异常，更改或修改和对齐。

Data Analysis and Documentation Requirements

The test protocol plan should also include the reporting requirements of your company’s internal reporting procedures. Similar to the methods section, the ASTM or ISO test standards outline the common deliverables for the testing. However, if you also require raw data, specific photographs, or inspections, these should be clearly outlined in this section. Statistical analysis information should also be outlined here for data evaluation.

The regulatory environment you plan on submitting to should also be considered. PMDA in Japan, for example, has different requirements than that of other regulatory bodies and requires additional information and flowcharts. Knowing this in advance will make it easier to capture the necessary data and take proactive measures to mitigate any submission risks.

参考

The References section should list any appropriate references, such as test standards, regulatory guidance, previous test reports, published literature, etc. This section helps identify where the information in the protocol came from and where to access that information for more details.

修订记录和Signatures

Once the protocol is completed, we recommend having signature and revision control to ensure that all parties are aware of any changes and to get everyone on the same page. Study owners, local management, and testing laboratory sign offs are common. Additional signatures can be added as required. This ensures multiple people have eyes on the program. A sample signature block is shown below. Depending on internal processes, some protocols have signature blocks on the front page, while others have them at the end.

结论

通常客户购买或开发一套amount of parts and have one opportunity to get testing programs right. There is a substantial difference in testing programs that have testing protocols implemented and those that do not. Always invest in a protocol and test plan. A protocol and plan will mitigate your risk, prevent confusion, set clear expectations, and preserve the necessary information for future reference and use.

元素是ISO 17025认可，并拥有世界上最广泛的医疗设备测试范围之一骨科和cardiovascular implants测试到EMC/EMI/product safety testing和生物和包装评估。联系我们to discuss how we can help with your test project.