新版医疗器械生产质量管理规范详细解读（五）-2

 第六章 设计开发（续）

第三十三条 企业应当在设计和开发的适宜阶段安排评审，保持评审结果及任何必要措施的记录。

美国820英文原文：

each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. the procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. the results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the dhf).

每个制造商应当建立和维护一个规程用以保证在器械设计开发的相应阶段设计结果正式文件化的审核得以策划和实施。该规程应当确保在每次设计审核中的参与者包括进行审核的设计阶段的所有职能代表，在需审核的设计阶段中不负有直接责任的一些个人，以及所需的专家。设计审核的结果包括设计识别、日期和实施审核的人员，应当记录在设计历史文档中。

iso13485-2016英文原文：

at suitable stages, systematic reviews of design and development shall be performed in accordance with planned and documented arrangements to:

在适当的阶段，应当根据策划和文件化的安排实施系统的设计和开发审核。以便：

a) evaluate the ability of the results of design and development to meet re;

评估设计和开发结果符合需求的能力；

b) identify and propose necessary actions.

识别并提出必要的措施。

participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel.

审核人员应当包括需审核的设计和开发阶段的职能部门人员和其他专业人员。

records of the results of the reviews and any necessary actions shall be maintained and include the identification of the design under review, the participants involved and the date of the review (see 4.2.5)

审核结果和任何必要的措施的相关记录应当予以保留，记录中包括审核下的设计识别、相关人员、审核的日期。（新增）（见4.2.5）

设计评审和审核怎么样，其实简单来讲就是一些专家人物的综合评估，但是一定不能是设计和开发自己部门人员自己搞。

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。

美国820英文原文：

each manufacturer shall establish and maintain procedures for verifying the device design. design verification shall confirm that the design output meets the design input re. 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.

每个制造商应当建立和维护一个程序用于器械设计的验证。设计验证应当证明设计输出符合设计输入的要求。设计验证的结果应当记录在设计历史文档中。这些结果包括设计识别、方法学、日期和实施审核的人员。

iso13485-2016英文原文：

design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs havemet the design and development input re.

设计和开发验证应当依据策划好的和文件化的方案来实施，从而保证设计和验证的输出能够符合设计和验证输入的要求。

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

组织应当建立验证计划，包括方法、接受标准、如果可以，样本大小的统计技术。（新增）

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

如果医疗器械的预期用途与其他医疗器械相连或有接口，当这样相连或接口时，验证应当包括设计输出满足设计输入的证明。（新增）

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

所有验证结论和结果以及必要的措施的记录都应当予以保留。（见4.2.4和4.2.5）

现在的“验证（verification）”就是注册检验。其实就是我们经常说的过程确认，但是大家记得过程确认（process validation），其实是真正的翻译是工艺验证。

Zui近国家局培训老师也强调了，药品和器械的确认和验证正好反过来了。不管怎么说其实就是都要通过连续三批次的证明性的操作、检测来得到符合质量标准的一种行为就对了。

第三十五条 企业应当对设计和开发进行确认，以确保产品满足规定的使用要求或者预期用途的要求，并保持确认结果和任何必要措施的记录。

第三十六条 确认可采用临床评价或者性能评价。进行临床试验时应当符合医疗器械临床试验法规的要求。

美国820英文原文：

each manufacturer shall establish and maintain procedures for validating the device design. design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their e design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. design validation shall include software validation and risk analysis, where appropriate. the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the dhf.

每个制造商应当建立和维护一个程序用于验证器械的设计。设计确认应当在规定的条件下（初始产品单元、批次或其等价物）进行。设计确认应当保证器械符合之前界定好的使用者需求和预期使用要求，设计确认应当包括在实际或等效的使用条件下的产品单元的测试。如果适用的话，设计确认应当包括适当的软件验证和风险分析。设计确认的结果包括设计的确定、方法学、日期、实施确认的人员应当记录在设计历史文档中。

iso13485-2016英文原文：

design and development validation shall be performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the re for the specified application or intended use.

设计和开发确认应当依据策划好的和文件化的方案来实施，从而保证产品能够满足适用要求或预期用途。

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

组织应当建立确认计划包括方法、接受标准、如果可以，样本大小的统计技术。（新增）

design validation shall be conducted on representative product. representative product includes initial production units, batches or their e the rationale for the choice of product used for validation shall be recorded(see 4.2.5).

设计确认应当用代表性的产品加以实施。代表性的产品包括初始产品单位、批量或其等价物。应当记录选择用于验证产品的统计技术。（见4.2.5）

as part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory re.

作为设计和开确认证的一部分，组织应当依据相应的法律法规实施医疗器械的临床评价或性能评价。

a medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer.

用于临床评价或性能评价的医疗器械不可以放行为客户使用。

if the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), validation shall include confirmation that the re for the specified application or intended use have been met when so connected or interfaced.

如果医疗器械的预期用途与其他医疗器械相连或有接口，当这样相连或接口时，验证应当包括使用要求和预期用途已经得到符合的证明。

validation shall be completed prior to release for use of the product to the customer. records of the results and conclusion of validation and necessary actions shall be maintained(see 4.2.4 and 4.2.5).

在产品交付使用者之前确认应当实施完成，确认的结果及任何必要措施应记录并予保留（见4.2.4和4.2.5）。

国家局培训老师曾经明确告知，现在的“确认”就是临床。

第三十七条 企业应当对设计和开发的更改进行识别并保持记录。必要时，应当对设计和开发更改进行评审、验证和确认，并在实施前得到批准。

美国820英文原文：

each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

每个制造商应当建立和维护一个程序在变更实施前用以对设计变更进行相应的识别、记录、验证或相应的确认、审核和批准。

iso13485-2016英文原文：

the organization shall document procedures to control design and development changes. the organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory re for the medical device and its intended use.

组织应当建立程序来控制设计和开发的变更。组织应当确定医疗器械的功能、操作、可用性、安全性和适当的法规要求和它的预期用途变更的重要性。

design and development changes shall be identified. before implementation, the changes shall be:

设计和开发变更应当被确定。在实施前，变更应当：

a) reviewed; 再审核

b) verified;确认

c) validated, as appropriate;适当的验证；

d) approved.批准。

the review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product in process or already delivered, inputs or outputs of risk management and product realization processes.

设计和开发变更的审核应当包括这些变更所产生的影响。这些变更包括过程中和已经交付产品和组件的变更、风险管理的输入和输出以及产品实现过程的变更。

records of changes, their review and any necessary actions shall be maintained (see 4.2.5).

变更，变更的审核和任何必须的措施的记录都应当予以保留（见4.2.5）

设计变更不是在设计开发的随时都有可能发生，所以有效控制才是上策。

第三十八条 企业应当在包括设计和开发在内的产品实现全过程中，制定风险管理的要求并形成文件，保持相关记录。

在产品的所有阶段都要有风险管理，这样才能将产品设计风险、开发风险降到Zui低。