医疗设备的QMS系统用于医疗设备？这项任务通常会延迟到以后的发展阶段。不要等待实施QMS；等待太久的后果会导致无法弥补的流程损害，在某些情况下会导致产品故障。医疗设备制造商面临着广泛的质量和合规性挑战。
Compliance with UDI, eMDR, ISO 13485:2016, MDSAP, EU MDR, and other global regulations are constant requirements in a highly competitive marketplace. Staying on top of medical device compliance is challenging enough, but new programs like the FDA’s Quality Metrics initiative are pushing the industry toward data-driven医疗设备的QMS系统关注结果。]
- QMS认证服务包括QMS认证培训，布局设计，制造和后市场支持，因为我们在审核，执行和维护所有功能方面具有监管专业知识。
- 我们的团队参与了前美国FDA，欧盟通知机构，QMS认证机构和医疗设备代理商专业人士具有良好的技术专业知识
一个医疗设备的QMS系统是一个结构化系统，用于记录整个部分甚至整个生命周期的过程和过程。它可以涵盖各种方面，例如医疗设备设计，制造，供应商管理，产品标签，存储和分销，临床数据，风险管理和投诉处理。
建立和管理高效医疗设备的QMS系统对于愿意将正确产品运送给客户的医疗设备企业来说，这是医疗设备企业的关键步骤。由于全球几乎所有的主要市场都使其在注册产品时通过合规QMS进行拇指规则，因此制造商的主要要求是维护QMS以成功推出产品。
在整个过程中，找到适合医疗设备的正确QMS系统并了解标准程序至关重要。这是一些有效的QMS元素。
Documentation
The fundamental elements of a医疗设备的QMS系统是文档和流程，质量事件，审核和工作流程。因此，拥有具有相关ISO标准的各个部分的质量手册（例如：ISO 13485）并了解其要求很重要。优质手册必须符合以下标准：
- Describe the scope of your QMS
- 列出包含QMS的过程
- Describe interactions of QMS processes
- 概述QMS文档的结构
医疗设备文件
医疗设备文件必须适用于具有以下内容的医疗设备的每种类型和家族：
- 产品描述，包括预期用途和使用指示
- 产品标签和使用说明
- Product specifications
- 制造，检查，标签，包装，存储，处理和分配的程序和规格
- 测量和监视规范
- 产品安装规格和程序（如果适用）
- 产品服务程序（如果适用）
组织结构和过程
- Executive management should create and implement quality policy and quality objectives
- The organization must dedicate enough quality resources for training, audits and assessments
- 一个designated executive must be responsible for the QMS and quality system reviews
- Create a policy for quality audits, document the audit findings and use the audit results to trigger corrective actions
- Hire the right and sufficient personnel with relevant experience and provide effective training
Corrective and Preventive Actions (CAPA)
To identify the quality problems within the QMS and device lifecycle, the QMS must include CAPA procedures. Below are some of the specific CAPA requirements that must be followed and documented:
- Root investigations must be performed on non-conformities
- 通过确定相关行动来防止经常出现的质量问题
- Verify or validate the effective actions
- 记录并采用CAPA产生的更改
- 在适当的情况下，统计方法可用于确定重复质量问题的风险
- The CAPA results must be included in the management review activities and made available to all the impacted personnel
Identification and Traceability
- 通过设备生命周期的所有阶段，有必要识别，追踪和追踪受潜在不利事件，召回和其他质量事件影响的产品
- 身份证明是要知道什么时候制造了什么产品，以及在任何相关质量事件的情况下，要拥有有关该产品在哪里的特定信息
- Identification and traceability recordsshould be maintained, and any product found to be non-conforming should be tagged and segregated from the conforming product
The above-mentioned elements are a foundation to have the right QMS for your organization and to ensure compliance with various Regulatory bodies. Even though a QMS will meet the requirements mentioned above, medical device development companies may find it best to hold off full QMS implementation until absolutely mandatory. That’s because especially in the very early stages of development, a full QMS can be burdensome and hinder the flexibility required。