7.3.9 Control of design and development changes 設(shè)計和開發(fā)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(yīng)當(dāng)建立程序來控制設(shè)計和開發(fā)的變更。組織應(yīng)當(dāng)確定醫(yī)療器械的功能、操作、可用性、安全性和適當(dāng)?shù)姆ㄒ?guī)要求和它的預(yù)期用途變更的重要性。
Design anddevelopment changes shall be identified. Before implementation, the changesshall be:
設(shè)計和開發(fā)變更應(yīng)當(dāng)被確定。在實施前，變更應(yīng)當(dāng)：
a) reviewed; 再審核
b) verified;確認
c) validated, asappropriate;適當(dāng)?shù)尿炞C；
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(shè)計和開發(fā)變更的審核應(yīng)當(dāng)包括這些變更所產(chǎn)生的影響。這些變更包括過程中和已經(jīng)交付產(chǎn)品和組件的變更、風(fēng)險管理的輸入和輸出以及產(chǎn)品實現(xiàn)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(yīng)當(dāng)予以保留（見4.2.5）
7.3.10 Design and development files 設(shè)計和開發(fā)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(yīng)當(dāng)為每一個醫(yī)療器械或系列醫(yī)療器械保留一份設(shè)計和開發(fā)文檔。該文檔應(yīng)當(dāng)包括或涉及相應(yīng)的記錄。這些記錄包含符合設(shè)計和開發(fā)要求的證明文件以及設(shè)計和開發(fā)變更的相關(guān)記錄。（新增）