每个制造商应当建立和维护一个程序用于器械设计的验证。
Each manufacturer shall establish and maintain procedures for verifying the device design.
前言：目的：为颈后路寰枢椎钛缆固定术和相关器械设计提供解剖学依据。
Objective: to provide anatomical basis for the operation of upper cervical posterior fixation with Atlas titanium cable and the related devices design.
每个制造商应当建立和维护一个程序来保证器械设计正确的转换成产品标准。
Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
目前的器械设计各不相同，带有干扰终板的突起的器械存在椎体损害相关并发症的可能。
While the current devices differ in design, those devices with keels violating the endplates present the risk of complications associated with vertebral body damage.
其结果是一个组织能够以所谓“受控状态”运行其医疗器械设计，工艺设计，生产流程及记录。
The result is an organization that is operating in a known state-of-control for the device design, process design, manufacturing processes, and records.
器械设计和制造工艺应当保证最大限度地降低甚至避免患者、使用者和其他人员之间交叉感染的可能性；
The devices and their manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties.
埃斯皮诺萨并没有很多闲余时间：白天她是一名医疗器械设计师，晚上要上夜校为了商业学位而且还要抚养她8岁的儿子，克里斯多夫。
Espinoza didn't have a lot of free time: a medical instruments designer by day, she was going to school for a business degree at night and raising her son, Christopher, then eight.
每个制造商应当建立和维护一个程序用于验证器械的设计。
Each manufacturer shall establish and maintain procedures for validating the device design.
Kowalski甚至说单独使用这些没有被设计成同时工作的器械对糖尿病的治疗也会有很大局限，尤其是在晚上。
Even so, Dr. Kowalski said, using separate devices that are not designed to work in concert poses limits to treatment, particularly overnight.
设计评审的程度和频率取决于所评估器械的复杂程度和重要性。
The extent and frequency of design reviews depends on the complexity and significance of the device being evaluated.
但是，市场调查和初期设计评审的目标之一就是建立完善的器械要求和规格以最大程度地减少后续的变更。
However, one goal of market research and initial design reviews is to establish complete device requirements and specifications that will minimize subsequent changes.
在实物设计工程的初期应该具有由输入规定衍生而来的成文的器械规格或成套的规格。
A documented device specification or set of specifications derived from the input requirements should exist at the beginning of the physical design project.
如果初期产品符合器械主记录和其他GMP的要求，并且通过设计验证，那么试生产的产品可以进入流通。
Pilot devices may be distributed after design validation of initial units is completed if they meet all of the device master record and other GMP requirements.
目的：综合分析硅橡胶在人造器官设计、医疗器械、整容术和在药物缓释体系的应用意义。
OBJECTIVE: To comprehensively analyze the application values of silicon rubber in the design of artificial organs, medical apparatus, facial plastic surgery and medical release system.
质量体系法规描述设计和生产医疗器械最少体系要素。
The Quality System regulation outlines the minimum elements of a system for designing and producing a medical device.
运动器械的设计需要经得起剧烈使用。
在设计控制体系下，生产商应该在设计输入阶段或者设计活动的开始就识别器械规定。
Under a design control system, manufacturers should identify device requirements during the design input phase or beginning of the design activity.
当设计成套的输入的规定被转换成工程术语，并在器械主记录中得到最终确认并成为记录一部分，这些成套规定就被称之为器械或产品规格。
A set of design input requirements, when converted to engineering terminology, finalized and accepted as part of the device master record is called a device or product specification.
设计确认应当保证器械符合之前界定好的使用者需求和预期使用要求，设计确认应当包括在实际或等效的使用条件下的产品单元的测试。
Design validation shall ensure that devices conform to defined user needs and intended USES and shall include testing of production units under actual or simulated use conditions.
攻城器械是种针对人型目标来杀伤的设计，而不是用于摧毁建筑和城堡。
Sieging is designed for anti-personnel design, rather than to destroying buildings or castles.
根据制造商的具体要求进行设计或检测部件或成品器械的合同实验室，被当作该制造商质量体系的延伸部分。
Contract laboratories that designs or test components or finished devices for a manufacturer are considered an extension of the manufacturer's quality system.
要我们设计测量器械是困难的。
六西格玛为医疗器械的设计，是第一本以接近主题为使用在医疗设备领域。
Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field.
顺应QS法规确保制造流程可以持续达到期望的质量水平，并使医疗器械达到其设计主文件规格要求。
Complying with the QS regulation assures that the manufacturing processes can consistently achieve desired levels of quality and that the finished device meets its device master record specifications.
目的：为新型脊柱前路短节段内固定器械的设计提供解剖学依据。
Objective: to supply the anatomical basis for the design of short segment anterior internal fixation instrument for the spine.
他设计并且采用了许多新的手术器械。
He designed and introduced numerous new operating instruments.
归结出家庭医疗器械必须以人性化设计为导向。
It then comes to the conclusion that the design of household medical appliance must be based on Humanizing Design.
然而，如果医疗器械的设计质量的不良，GMP的生产控制只能保证制造不良质量的医疗器械。
However, if the device as designed is of poor quality, the GMP production controls will only assure that a poor quality device is manufactured.
我公司是专业从事一次性使用医疗器械产品价格研发、生产和模具设计制造、销售的企业。
Our company is specialized in researching, producing disposable medical instruments and developing, selling all kind of moulds.
我公司是专业从事一次性使用医疗器械产品价格研发、生产和模具设计制造、销售的企业。
Our company is specialized in researching, producing disposable medical instruments and developing, selling all kind of moulds.
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