无源医疗器械设计开发期间，设计验证是非常重要的一部分。做设计验证之前，首先问自己一个问题:为什么要做设计验证？

图1 – 将设计控制应用于瀑布设计过程

资料来源：FDA 《DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS》（所用的图得到加拿大卫生部医疗器械局的许可）

1.什么是设计验证？

首先，我们要知道什么是设计验证：

设计验证：证实设计和开发输出满足输入的要求。即设计验证是在每个阶段检查输出是否符合该阶段要求的过程。

例如：设计输入是否已被转换为一种可以被充分验证的形式？器械实际尺寸是否与图纸相符？产品包装是否保护器械免受任何存储和运输的不利影响？器械是否耐受所选择的灭菌方法？所选择的灭菌方法是否能保证产品无菌？等等。

2. 设计验证的法规标准要求

其次，从法规标准的角度，看一下各国市场法规标准中对于设计验证要求的来源：

NMPA国内市场

1.《GB/T 42061-2022 医疗器械 质量管理体系用于法规的要求》

7.3.6设计和开发验证

为确保设计和开发输出满足设计和开发输入的要求，应依据所策划并形成文件的安排对设计和开发进行验证。

组织应将验证计划形成文件，验证计划包括方法、接收准则，适当时包括包含样本量原理的统计技术。

如果预期用途要求医疗器械连接至或通过接口连接至其他的一个或多个医疗器械，验证应包括证实当这样连接或通过接口连接时设计输出满足设计输入的要求。

应保留验证结果和结论及必要措施的记录（见4.2.4和4.2.5）

2.《医疗器械生产质量管理规范》

第三十四条　企业应当对设计和开发进行验证，以确保设计和开发输出满足输入的要求，并保持验证结果和任何必要措施的记录。

CE市场

1.《ISO 13485:2016》

7.3.6 Design and development verification

Design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements.

The organization shall document verification plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.

If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), verification shall include confirmation that the design outputs meet design inputs when so connected or interfaced.

Records of the results and conclusions of the verification and necessary actions shall be maintained (see 4.2.4 and 4.2.5).

2. MDR REGULATION (EU) 2017/745

6. PRODUCT VERIFICATION AND VALIDATION 

The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements. 

(a)results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;

(b) detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular

(c) the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;

(d)the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.

FDA市场

《QSR 820.30》

(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design . Design verification shall confirm that the design output meets the design input requirements.  The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification , shall be documented in the DHF.

《QSR 820.250》 

(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics .

(b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented. 

3. 设计验证的目的

设计验证的目的是提供客观证据以证明你的设计要求已经满足，如果设计要求没有满足，则需要表明设计离达到要求还有多远。设计验证确保在进入设计确认之前是经过验证的设计。

4. 设计验证的重要性

在设计开发过程的早期（如定义设计输入时）就应该考虑设计验证。

设计验证是所有注册申报的一个重要因素，监管机构将寻找客观证据，以判定你的医疗器械符合安全性和有效性的基本要求。