课程1：ISO13485医疗器械质量体系内审员培训课程
ISO13485 QMS Internal auditor training
一、标准基础知识Basic knowledge of the Standard
ISO13485标准的产生与发展ISO13485 history and development
八项质量管理原则Quality management principles
ISO3485质量管理体系基础the basic of ISO13485
基本术语Terms and definitions
ISO13485的理解要点ISO13485 management system requirements
1范围scope
2引用标准references
3医疗器械专用术语和定义Terms and definitions
4质量管理体系Quality management system
5.管理职责Management responsibility
6资源提供Resource management
7.产品实现Product realization
8.测量、分析和改进Measurements, analysis and improvement
二、审核知识Audit
审核基本知识basic knowledge of audit
审核过程Audit process
审核实施Audit implementation
审核的后续活动实施Succeed action after audit
三、案例研讨与考试Case study and test
案例研讨Case study
考试Test
课程2：ISO13485质量管理体系文件编写的培训
ISO13485 QMS documentations preparation & writing training
ISO13485标准要求回顾
ISO13485 Standard requirements
过程方法
Process approach
ISO13485体系文件的策划
ISO13485 management system documentations plan
ISO13485文件流程的标准格式
The standard form of the process and flow chart
ISO13485文件内容的标准格式
The standard form of the document contents
ISO13485文件内容的展开
How to draft the document
课程3：医疗器械风险管理培训
Medical device risk management training
风险管理的历史发展与现状
Medical device risk management history and actuality
ISO14971:2007《医疗器械风险管理对医疗器械的应用》I
SO14971:2007:"Medical devices-Application of risk management to medical devices"
医疗器械风险管理过程和技术
Medical devices risk management process and technology
医疗器械风险管理报告的编写及案例分析
Medical devices risk management report writing and case study
课程4：MDD指令及FDA培训
MDD&FDA training
欧洲共同体新方法指令介绍EU latest MDD introduction
医疗器械指令：MDD contents
定义、范围Definition and scope
适用对象Application
基本框架Essential requirements
新概念New concepts
CE标志CE mark
产品分类Classification of Medical devices
合格评定程序Evaluation and accreditation process
MDD基本要求及标准MDD basic requirements
临床评估Clinical assessment
公告(指定)机构Notified Body
警戒系统和售后监督Medical devices vigilance system and after sale surveillance audit
保护条款Safeguard clauses
MDD指令的实施MDD implementation
FDA要求的医疗器械产品分类 Classification of medical devices based on FDA
FDA法规和指南要求FDA regulation and guideline requirements
FDA上市审批流程FDA registering and approving process
美国国内服务代理商的评估和选择FDA service agent evaluation and selection
产品测试的指导和帮助Medical devices test
510（K）文件的提交内容和流程510(K) documentations submitted process
产品的注册申报Medical devices declaring
IEC60601-1医用电气设备安全通用要求培训
IEC60601-1 Medical Electrical Equipment- Part 1:General requirements for basic safety and essential performance training
一、 概述
二、 环境条件
三、 对电击危险的防护
四、 对机械危险的防护
五、 对不需要的或过量的辐射危险的防护
六、 对易燃麻醉混合气点燃危险的防护
七、 对超温和其他方面安全危险的防护
八、 工作数据的准确性和危险输出的防止
九、 不正常的运行和故障状态，环境试验
十、 结构要求
