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21 CFR820.30(b)

Clause7.3.2 of ISO 13485

China GMP條款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.企業(yè)應(yīng)當(dāng)建立設(shè)計(jì)控制程序并形成文件，對(duì)醫(yī)療器械的設(shè)計(jì)和開發(fā)過程實(shí)施策劃和控制。

每個(gè)制造商應(yīng)建立并維護(hù)設(shè)計(jì)開發(fā)策劃用于描述或引用設(shè)計(jì)開發(fā)活動(dòng)并明確實(shí)施的職責(zé)。

組織應(yīng)對(duì)產(chǎn)品的設(shè)計(jì)和開發(fā)進(jìn)行策劃和控制。適當(dāng)時(shí)，伴隨設(shè)計(jì)和開發(fā)的進(jìn)程，應(yīng)保持并更新設(shè)計(jì)和開發(fā)策劃文件。

29.在進(jìn)行設(shè)計(jì)和開發(fā)策劃時(shí)，應(yīng)當(dāng)確定設(shè)計(jì)和開發(fā)的階段及對(duì)各階段的評(píng)審、驗(yàn)證、確認(rèn)和設(shè)計(jì)轉(zhuǎn)換等活動(dòng)，應(yīng)當(dāng)識(shí)別和確定各個(gè)部門設(shè)計(jì)和開發(fā)的活動(dòng)和接口，明確職責(zé)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:

計(jì)劃應(yīng)識(shí)別并描述不同小組或活動(dòng)之間的接口，這些接口為設(shè)計(jì)和開發(fā)過程提供或產(chǎn)生輸入。

a)the design and development stages; 設(shè)計(jì)和開發(fā)階段；

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

b)the review(s) needed at each design and development stage; 每個(gè)設(shè)計(jì)和開發(fā)階段的評(píng)審

隨著設(shè)計(jì)開發(fā)的展開，計(jì)劃應(yīng)被評(píng)審，更新，批準(zhǔn)。

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

每個(gè)設(shè)計(jì)和開發(fā)階段的驗(yàn)證，確認(rèn)，和設(shè)計(jì)轉(zhuǎn)換活動(dòng)。

d)the responsibilities and authorities for design and development; 

設(shè)計(jì)和開發(fā)的職責(zé)和權(quán)限

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

確保設(shè)計(jì)和開發(fā)輸出到設(shè)計(jì)和開發(fā)輸入的可追溯方法

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

所需的資源，包括必要的人員能力。