Medical devices having direct or indirect impact on lives of its users. Why there is need of understanding of quality control process for medical devices, the reason is that manufacturer wants surety of the medical devices and their effectiveness. The main target of the any medical device is to improve the lives of their users. But what if a product fails to perform as it should? What happens if a device fails or harms a patient? How can we be certain that medical devices work well and are safe to use?
The necessity for a quality management system (QMS) arises. When medical devices are made, they must be thoroughly examined using appropriate measures as part of a Quality Control system of which the Quality Control process is an essential component. Let’s take a closer look at what Quality Control means for medical devices, why it’s important, and how to improve your own medical device Quality Control process.
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What does a Quality Control Process for Medical Devices Look like?
根据该定义，医疗设备的质量控制过程既具有反应性，又是面向产品的。这些操作是在生产期间和生产后以及产品之前分配给客户的。质量控制程序检查单个产品或产品批处理是否符合产品规格，并且没有缺陷或缺陷。 Quality Control department in medical device manufacturing utilize a number of procedures and metrics to identify nonconforming items. Any Quality Control approach should concentrate on three primary areas:
验收标准：FDA要求质量控制人员创建一个正式的文件，概述他们将如何确定产品是否符合产品标准。质量控制人员还负责记录陈述的接受并跟踪哪些物品或批次所做的，也不符合标准。
产品检查，测试和验证：质量控制personnel are supposed to inspect, test, and verify if a product is ready for shipment. Medical device manufacturers have the ability to design their own Quality Control tests under FDA’s quality system regulation, but FDA wants extensive documentation that confirms the verification’s performance.
纠正和预防措施（CAPA）管理：什么时候质量控制personnel detect a nonconforming product, conduct a root cause investigation, and discover a systemic defect that caused the non – conformance, these investigative events are initiated.
Who is involved in Quality Control process for medical device?
根据ISO 9001，质量控制是“质量管理的一个方面，专注于满足质量要求”。国际标准继续列出基本质量控制过程要求，其中之一是能力，其中包括员工知识，技能，经验和认证。
质量控制专业人员的主要作用是检查，例如检查设备是否有裂缝或损坏的组件。医疗设备很复杂；为了确保这些产品没有缺陷，需要一组经过训练，有能力和勤奋的检查员，并配备了上述接受标准文件所规定的广泛知识。
质量控制与质量保证
质量控制and quality assurance both are part of same quality management system, their roles and responsibilities are not much different.质量保证可以阻止医疗设备制造过程中的缺陷。整个医疗设备制造过程中的质量保证法。优质的人员寻找可能导致不合格产品的流程中的问题。
但是，对于质量控制，主要问题是产品而不是过程。质量控制测试直到批次或大量医疗设备准备发货才开始，此时，该专业团队负责检查和对批次或批次进行最终审查，以确保设备准备好出售。
How to evaluate your own quality control process?
每个医疗设备制造商都需要仔细考虑它如何接近质量。质量计划可以通过多种方式进行，例如关于质量管理或建立实际质量系统的高级想法。
Activities like onsite inspections of physical product are often more tangible.那么，在评估自己的医疗设备公司的质量控制流程时应该看起来应该看起来什么？
- Establish a quality management plan
具体而言，ISO 13485要求制定质量管理计划，该计划定义了“与设计和制造的设备相关的质量实践，资源和活动”。 It will help to spread light on what is being tested by quality control, how the roles of quality control fit within the entire QMS and which responsibilities are required for each team member and department.
- Collaboration with product developers for quality control insights
质量控制methods can be considerably enhanced by addressing device specifics with the design team, in the same spirit of collaboration. Few people know a product’s inner workings better than its engineers, and they’ll be able to explain device inputs and point out any flaws in your quality control testing.
- Write descriptive acceptance requirements
建立有效的接受标准是质量控制过程的核心。由于本文档包含明确的标准，可以评估适合拟合的设备，因此评估用于定义质量控制团队的功能的语言至关重要。 Requirements should be defined clearly and plainly, but they should also prevent information overload, which could lead to testers flagging a product as nonconforming unnecessarily.
- 创建详尽的文档
Documentation, like every other aspect of the medical device life cycle, is critical to the quality control process. This is evidenced by regulatory requirements such as the FDA’s 21 CFR Part 11, which calls for quality control testing paperwork. 您必须跟踪设备生命周期期间不可避免的修改也至关重要。确保您使用可追溯性矩阵来跟踪所有设计更改，输入，输出和用户需求。 Your acceptance criteria may be affected by changes in your traceability. Keep track of any changes to the acceptance criteria and make sure that quality control personnel are trained on the new procedures.
以上讨论的观点使我们对医疗设备的质量控制过程.医疗设备的质量控制过程is necessary for the safety for public health as the devices直接或indirectly used by the patients.