7.3.9 Control of design and development changes 设计和开发变更的控制

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.

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 anddevelopment changes shall be identified. Before implementation, the changesshall 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, asappropriate;适当的验证；

d) approved.批准。

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.

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 ofchanges, 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）

7.3.10 Design and development files 设计和开发文档

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.

组织应当为每一个医疗器械或系列医疗器械保留一份设计和开发文档。该文档应当包括或涉及相应的记录。这些记录包含符合设计和开发要求的证明文件以及设计和开发变更的相关记录。（新增）