Design and development validation shall be performed in accordance with planned arrangements ( see 7 . 3 . 1 ) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use , where known 设计与开发的确认应依规划的安排执行(见7 . 3 . 1 )以确保最终产品能符合已知的特定应用或预期使用的需求。
Design and development validation shall be performed in accordance with planned arrangements ( see 7 . 3 . 1 ) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use , where known 为确保产品能够满足规定的使用要求或已知预期用途的要求,应依据所策划的安排(见7 . 3 . 1 )对设计和开发进行确认。