US FDA 21 CFR 820.30 Design Control Requirements
什么是FDA 21 CFR 820.30设计控制？
FDA 21 CFR第820.30部分设计控制要求是医疗设备进步的最重要阶段，因为有缺陷的计划可能会促使其不足或危险（即行政组织肯定或清除）。在设计阶段，应启动并将其作为质量系统要求的特征进行大纲设计控制过程。通常，概述设计控件是直接且逻辑上的步骤，以确保您开发的内容是您要开发的意思，并且最后一项符合客户的需求和欲望。
我们在每个组成部分和GMP法规方面都有经验，共同构成了其开发和制造的基础：Drug Device Combination Products（FDA 21 CFR第820部分）和（21 CFR第4部分）。
Design Control 21 CFR 820.30 Process for Medical Devices :
建立并维护一个描述设计和开发活动的计划，并为每项活动分配个人义务。保证您审查，更新和批准计划，直到设备设计完成，验证和验证。
建立并维护一个描述设计和开发活动的计划，并为每项活动分配个人义务。保证您审查，更新和批准计划，直到设备设计完成，验证和验证。
Design Input :
利用绩效，安全性，商业经济学，风险管理的产出和监管要求作为计划设备的基础，其目标是明确的。输入也可能来自调查您的客户（例如，临床医生，护士，患者）。
Design Output :
设计输出方法或详细信息需要规定或参考团队开发的设计输入文档，并且需要确定设备最佳能力的关键措施/输出。这些结合了可能已生成，调整或用于表现出与特征配置输入的一致性的测试和策略。设计输出的示例可能包括：
- 设备本身。
- The user manual.
- Specifications A Risk Analysis Study results (For examples, validation and biocompatibility studies, storage).
- 技术文件。
Design Review :
确认设计，或在其他计划和改进阶段区分的任何不足之处确定并正确确定。两种常见的审查类型是危害分析以及失败模式和效果分析。
设计验证：
Confirm the device outline by means of examination and target prove, verify that the design outputs meet the plan inputs. Design verification activities must be arranged and routinely analyzed and the outcomes must be documented.
Design Validation :
Approve the device design plan by means of examination and target prove, affirm that the last outline yield reliably meets the particular planned utilize. Design validation should follow successful design verification. Since outline check is directed while the plan work is being performed, design validation confirms that the medical device meets its intended use. Generally, this is set up through in vitro execution, practical testing, creature testing and additionally in vivo clinical assessments and trials.
设计更改：
确保所有计划更改在使用前都有区分，记录，批准，验证，审查和认可。
Design Transfer :
Ensure that the design of the medical device can be correctly translated into production specifications (that is, advancing successfully from product development to manufacturing).
设计历史记录文件：
The design history file (DHF) aggregates confirm (that is, the history of the design) that demonstrates that the outline was created as per outline of design control― specifically, the design and development plan, or the outline change design.
Operon Strategist the leading医疗设备监管顾问为21 CFR 820.30提供咨询设计有限公司ntrol with extensive experience and the practical implementation of design controls regulation for developing new design control processes or for making improvements to existing processes. We assist in design controls as per FDA andISO 13485:2016 that can be mapped to the process that works best for the organization and the product being developed. If you need any help setting up a design control system, or wish to modify an existing system in order to align withISO 13485或FDA设计控件，请与我们联系。
常问问题's
Design Control labels the implementation of a formalistic technique to the ways of product development activities. It is often necessary by regulation for the appliance of such practice when designing and developing products within regulated industries e.g. medical devices. The Food and Drug Administration FDA has stated that medical device manufacturers that want to marketized certain classifications of medical devices in the USA follow design control requirements (21 CFR 820.30). Few firms regard Risk Management and Design Control as they are linked together but they follow separate procedures, not actualizing that the relation between the user needs, design inputs, dangers and dangerous circumstances. Design control conditions that when the suppliers or manufacturers get a product to design controls they may discover and maintain the correct documentation to assure the specified design requirements are.
ISO:ISO 13485is the worldwide acknowledged standard by the International Standards Organization for medical device Quality Management System. The standard states the things required forQMS这可以帮助公司执行并展示能力提供高质量的医疗设备，以符合客户和监管要求。ISO 13485可以由参与医疗设备转移，提供支持阶段的任何公司使用。此外，外部或内部审计师也可以使用它来支持包容性审计过程。
21 CFR Part 820:FDA 21 CFR第820部分：涵盖用于设计，制造，包装，标签，存储，安装和医疗设备的设计的设施和控件中使用的过程和控件。根据第820部分，美国FDA对制造商进行了检查，并且仅评估了遵守要求。FDA 21 CFR被称为质量系统法规QSR确认当前良好的制造实践CGMP法规，该法规管理使用的方法以及用于所有成品设备的设计，制造，包装，标签，存储，安装和服务的服务以及使用的控件故意人类使用。这些要求是必要的，以确保医疗设备安全可用。医疗设备制造商接受FDA检查以确保FDA 21 CFR 820协议。
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