概述:描述根据客户投诉程序，如果投诉可能是可报告事件，应遵循的程序。解释如何决定是否报告事件以及向哪个主管部门报告。适用于根据《医疗器械指令》（93/42/EEC）规定在欧洲上市或投入使用的带有CE标志的医疗器械。包括初步调查、报告和最终决定。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括附件/附录: 程序流程图、初始事件报告表、最终报告表关于本文件:这不是一个通用模板，它是一个11页的程序，实际上是在FDA监管机构的监管事务运作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，哪些公司会从中受益: 监管事务经理管理代表执行管理

Summary:Describes a procedure to be followed in case a complaint may be a reportable event according to Customer complaint procedure. Explains how to make the decision on whether to report the event and to which Competent Authority. Applicable to CE marked medical devices which are placed on the market or put into service in Europe under the provisions described in the Medical Device directive (93/42/EEC). Covers decision process, initial reporting, investigation, final reporting and decision criteria.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Procedural Flow Chart, Initial Incident Report Form, Final Report FormAbout This Document:This is not a generic template, it's a 11-page procedure that was actually created and used in the Regulatory Affairs operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Regulatory Affairs ManagersManagement RepresentativesExecutive Management