7.3.9 Control of design and development changes 設計和開發變更的控制

The organizationshall document procedures to control design and development changes. The organizationshall determine the significance of the change to function, performance,usability, safety and applicable regulatory requirements for the medical deviceand its intended use.

組織應當建立程序來控制設計和開發的變更。組織應當確定醫療器械的功能、操作、可用性、安全性和適當的法規要求和它的預期用途變更的重要性。

Design anddevelopment changes shall be identified. Before implementation, the changesshall be:

設計和開發變更應當被確定。在實施前，變更應當：

a) reviewed; 再審核

b) verified;確認

c) validated, asappropriate;適當的驗證；

d) approved.批準。

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

設計和開發變更的審核應當包括這些變更所產生的影響。這些變更包括過程中和已經交付產品和組件的變更、風險管理的輸入和輸出以及產品實現過程的變更。

Records ofchanges, their review and any necessary actions shall be maintained (see 4.2.5).

變更，變更的審核和任何必須的措施的記錄都應當予以保留（見4.2.5）

7.3.10 Design and development files 設計和開發文檔

The organizationshall maintain a design and development file for each medical device type ormedical device family. This file shall include or reference records generatedto demonstrate conformity to the requirements for design and development and records for design anddevelopment changes.

組織應當為每一個醫療器械或系列醫療器械保留一份設計和開發文檔。該文檔應當包括或涉及相應的記錄。這些記錄包含符合設計和開發要求的證明文件以及設計和開發變更的相關記錄。（新增）