相关文件：
与验证、确认相关的主要法规和标准
1.21CFR PART 820 QUALITY SYSTEM REGULATION.
2.DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS.
3.ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices.
4.GHTE/SG3/N99-10 Quality Management Systems -Process Validation Guidance
5.GB/T 42061—2022/ISO 13485:2016 医疗器械 质量管理体系 用于法规的要求
术语的定义：
Specification规范
means any requirement with which a product, process, service, or other activity must conform.
产品、过程、服务或其他活动必须符合的任何要求。
Validation 确认
means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
指通过审查和提供客观证据来证明特定预期用途的特殊要求能够持续得到满足。
Process validation 过程确认
means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
指通过客观证据证明过程始终如一地产生符合预定规范的结果或产品。
establishment by objective evidence that a process consistently produces a result or device achieving its predetermined requirements.
通过客观证据证明过程始终如一地产生符合预定要求的结果或器械。
Process validation protocol 过程确认方案
a document stating how validation will be conducted, including test parameters, product characteristics, manufacturing equipment, and decision points on what constitutes acceptable test results.
说明确认将如何实施的文件，包括测试参数、产品特性、生产设备以及测试结果的接收准则。
Design validation 设计确认
means establishing by objective evidence that device specifications conform with user needs and intended use(s).
指通过客观证据证明产品规范符合用户需求和预期用途。
establishing by objective evidence that the device conforms to defined user needs and intended use(s).
通过客观证据证明器械符合规定的用户需求和预期用途。
Verification 验证
means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
指通过审查和提供客观证据证明规定的要求已经得到满足。
验证
通过提供客观证据对规定要求已得到满足的认定。
确认
通过提供客观证据对特定的预期用途或者应用要求已得到满足的认定。
关键工序
指对产品质量起决定性作用的工序。
特殊过程
指通过检验和试验难以准确评定其质量的过程。
法规的要求：
Design verification 设计验证
Each manufacturer shall establish and maintain procedures for verifying the device design.
每个制造商应建立和维护验证器械设计的程序。
Design verification shall confirm that the design output meets the design input requirements.
设计验证应证明设计输出满足设计输入的要求。
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.
设计验证的结果，包括设计的识别、方法、日期和执行验证的人员，应记录在DHF中。
confirmation by examination and provision of objective evidence that the device design (design output) fulfills the specified requirements (design input).
通过审查和提供客观证据证明器械设计(设计输出)满足规定的要求(设计输入)。
为确保设计和开发输出满足设计和开发输人的要求, 应依据所策划并形成文件的安排对设计和开发进行验证。（GB/T 42061 / ISO 13485）
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。（医疗器械生产质量管理规范）
Design validation 设计确认
Each manufacturer shall establish and maintain procedures for validating the device design.
每个制造商应建立和维护确认器械设计的程序。
Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.
设计确认应在规定的操作条件下对初始生产单元、批次、批次或其等同物进行。
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.
设计确认应确保器械符合规定的用户需求和预期用途，并应包括在实际或模拟使用条件下对生产单元的测试。
Design validation shall include software validation and risk analysis, where appropriate.
适当时，设计确认应包括软件确认和风险分析。
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.
设计确认的结果，包括设计的识别、方法、日期和执行确认的人员，应记录在DHF中。
为确保形成的产品能够满足规定的应用要求或预期用途，应依据策划并形成文件的安排对设计和开发进行确认。（GB/T 42061 / ISO 13485）
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。（医疗器械生产质量管理规范）
Process validation 过程确认
Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
如果一个过程的结果不能通过后续的检查和测试得到充分的验证，则该过程应进行高度保证的确认，并按照既定的程序进行批准。确认活动和结果，包括批准确认的人员的日期和签名，以及在适当的情况下对已确认的主要设备，应形成文件。
Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
每个制造商应建立并保持经过程确认的工艺参数进行监视和控制的程序，以确保持续满足规定的要求。
设计评审、验证与确认的关系：
In practice, design review, verification, and validation overlap one another, and the relationship among them may be confusing. As a general rule, the sequence is: verification, review, validation, review.
在实践中，设计评审、验证和确认是相互重叠的，并且它们之间的关系可能是令人困惑的。一般来说，顺序是：验证、评审、确认、评审。
Verification and validation are associated concepts with very important differences.Various organizations have different definitions for these terms. Medical device manufacturers are encouraged to use the terminology of the quality system requirements in their internal procedures.
验证和确认是具有非常重大差异又相关联的概念。不同的组织对这些术语有不同的定义。鼓励医疗器械制造商在其内部程序中使用质量体系要求的术语。
过程确认决策树：
Process validation decision tree过程确认决策树
Each process should have a specification describing both the process parameters and the output desired. The manufacturer should consider whether the output can be verified by subsequent monitoring or measurement (A). If the answer is positive, then the consideration should be made as to whether or not verification alone is sufficient to eliminate unacceptable risk and is a cost effective solution (B). If yes, the output should be verified and the process should be appropriately controlled (C).
每个过程都应该有一个描述过程参数和期望输出的规范。制造商应考虑输出是否可以通过后续的监视或测量进行验证(A)。如果答案是肯定的，则应考虑单独验证是否足以消除不可接受的风险，并且是一种具有成本效益的解决方案(B)。如果是，则应验证输出并对过程进行适当控制(C)。
If the output of the process is not verifiable then the decision should be to validate the process (D); alternatively, it may become apparent that the product or process should be redesigned to reduce variation and improve the product or process (E). Also, a change in a manufacturing process may result in the need for process validation even though the process formerly only required verification and control.
如果过程的输出是不可验证的，那么应该决定对该过程进行确认(D)；或者，该产品或工艺很显然地应该重新设计以减少变化并改进产品或工艺(E)。此外，生产工艺的变化可能导致需要做过程确认，即使该工艺以前只需要验证和控制。
验证与确认总结：
确认：是从用户的角度或者能够是模拟用户角度来验证产品是否和客户想要的一致；
验证：是从开发方的角度来做评审、测试来验证产品的需求、架构设计等方面是否和输入要求的一致；
在开发阶段有：
○ 设计验证：确保设计和开发输出满足输入的要求
○ 设计确认：确保产品满足规定的使用要求或者预期用途的要求
为满足设计转生产的需求有：
○ 工艺验证：对关键工序做验证
○ 过程确认：对特殊过程做确认
进一步的理解：
● 验证针对的是结果，确认针对的是过程；
● 验证采取的方法通常是试验法，确认采取的是系统的方法；
● 验证的结果是证实被试验的对象在某一条件下符合规定的要求。确认的结果是证实运用该过程可以在某个范围内持续产出符合要求的输出；
● 验证要保证“做得正确”，确认则要保证“做的东西有用”；
● 验证注重“过程”，确认注重“结果”；
● 验证是自我视角，确认是客户视角；
● “验证”是要证明我们“做好”产品，“确认”是要证明我们“做的产品好”；
