设计和开发确认必须按照顾客的要求包括时间进度进行。
Design and development validation shall be performed in accordance with customer requirements including programme timing.
如果适用的话，设计确认应当包括适当的软件验证和风险分析。
Design validation shall include software validation and risk analysis, where appropriate.
使用本检查表，帮助确认检查您考虑的重要方面部分的设计，包括材料的选择、装配技术，以及模具问题。
Use the checklist as an aid to ensure that you consider the important aspects of part design, including material selection, assembly techniques, and mold concerns.
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