后市场监视系统(PMS) refers to the requirement that manufacturers monitor their medical devices after being approved for sale and seeing in-market use. PMS is a regulatory requirement in significant markets, including the European Union (EU) and the United States (US).
后市场监视系统relies on reactive data gathering. Manufacturers collect and report adverse events from a device post-market, often using manual methods. These adverse events are either directly reported to the manufacturer or they could be reported to Regulatory bodies like FDA in the US (MAUDE database), MHRA in the UK, Health Canada in Canada etc.
- 188金宝搏网站靠谱吗操纵子战略家是FDA 510 K流程顾问如果适用，请帮助客户注册SBU（小型企业单位）。取出产品的测试要求，创建档案，解决查询以及完成所有活动后，客户将获得美国FDA 510 K批准。
- 我们还协助建立注册和设备清单，以使美国的医疗设备供应合适。
FDA 510 K Clearance＆Market批准医疗设备
188金宝搏网站靠谱吗操纵子策略师是FDA 510 K流程顾问，如果适用，请客户注册SBU（小型企业单位）。删除产品的测试要求，创建档案，解决查询以及完成所有活动后。
我们什么 Contact Us制造商有义务调查每个医疗设备报告（MDR），并在给定时间段内通知监管机构，以提供其评估MDR是否与设备相关的事件。这种方法继续重新评估医疗设备的利益/风险比以及其在市场后阶段的安全性和有效性。
这后市场监视系统不仅可以满足监管要求，还可以改善风险管理并改善医疗设备的质量。这后市场监视系统还可以适当地确定设备设计和/或使用中的问题，并在正常使用条件和获得的临床结果中准确表征设备的行为。
后市场监视系统
这FDA has government authorization to require post-market surveillance for class II and class III medical devices that meet one of four criteria:
该设备的故障很可能会产生严重的不良健康后果。该设备旨在植入人体一年多。这device is intended to be a life-sustaining of life-supporting device used outside of a user facility.
FDA可以命令重新上市后监测sponse to adverse event reports, to assess safety and effectiveness of devices that have undergone limited pre-market testing, or to obtain more information on device performance in real-world clinical practice.
FDA将发布后市场监视的订单，要求制造商提交市场监视系统。该计划必须包含有助于满足原始PMS订单理由的元素。列出了PMS报告中的典型夹杂物：
- Background of the device, regulatory history, description, and indications for use
- Purpose of the后市场监视系统
- 后市场监视系统目标和假设
- PMS design
- Patient population (include inclusion and exclusion criteria for patients)
- 统计合理的样本量计算
- 主要和次要终点，包括定义，研究的成功标准，预期的并发症的不良事件列表以及收集意外不良事件的协议
- Descriptions of the follow-up schedule, length, and assessment procedures
- Relevant data collection forms and description of data collection procedures and statistical analysis
- 报告和最终报告的报告时间表
- Interim and final data analyses
- 里程碑/时间轴元素
Post Market Surveillance Plan
A postmarket surveillance plan is a systematic process that is designed for the monitoring of a specific device. Note that each individual device requires its own PMS plan.尽管不同设备的计划可能具有很多相似之处，但您不能简单地将PMS计划从一台设备重复使用。您的PMS计划必须定义应监视哪些数据，应如何收集以及如何调查或确定可报告趋势。
这type of data collected will vary depending on the product, but a postmarket surveillance plan should always include:
- 对严重和非严重事件的调查。
- 不良副作用的报告。
- Analysis of trends.
- 用户，分销商或进口商的反馈 - 包括投诉。
- 有关类似设备的公开信息以及来自文献，数据库或其他来源的相关信息。
Post-market surveillance system is a crucial tool to ensure that medical devices continue to be safe and well-performing and to ensure actions are undertaken if the risk of continued use of the medical device outweighs the benefit. The evaluation of post-market surveillance experiences can also highlight opportunities to improve the medical device.