21 CFR820.30(b)

Clause7.3.2 of ISO 13485

China GMP条款28、29

Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. 

The organization shall plan and control the design and development of product. Asappropriate, design and development planning documents shall be maintained andupdated as the design and development progresses.

28.企业应当建立设计控制程序并形成文件，对医疗器械的设计和开发过程实施策划和控制。

每个制造商应建立并维护设计开发策划用于描述或引用设计开发活动并明确实施的职责。

组织应对产品的设计和开发进行策划和控制。适当时，伴随设计和开发的进程，应保持并更新设计和开发策划文件。

29.在进行设计和开发策划时，应当确定设计和开发的阶段及对各阶段的评审、验证、确认和设计转换等活动，应当识别和确定各个部门设计和开发的活动和接口，明确职责和分工。

The plans shall identify and describe the interfaces with different groups or activitiesthat provide, or result in, input to the design and development process.

During design and development planning, the organization shall document:

计划应识别并描述不同小组或活动之间的接口，这些接口为设计和开发过程提供或产生输入。

a)the design and development stages; 设计和开发阶段；

The plans shall be reviewed, updated, and approved as design and development evolves.

b)the review(s) needed at each design and development stage; 每个设计和开发阶段的评审

随着设计开发的展开，计划应被评审，更新，批准。

c)the  verification, validation, and design transfer activities that appropriate at each design and development stage 

每个设计和开发阶段的验证，确认，和设计转换活动。

d)the responsibilities and authorities for design and development; 

设计和开发的职责和权限

e)the methods to ensure traceability of design and development outputs to design and development inputs;

确保设计和开发输出到设计和开发输入的可追溯方法

f)the resources needed,including necessary competence of personnel. 

所需的资源，包括必要的人员能力。