序号
NO。
培训课程
Training Course
课时(天)
1
ISO9001:2015质量管理体系要求
ISO9001:2015
Quality Management Systems Requirements
2
2
ISO13485:2016医疗器械质量管理体系适用于法规的要求
ISO13485:2016
Medical Devices--Quality Management SystemsRequirements
2
3
93/42/EEC (2007/47/EC)医疗器械指令
93/42/EEC(2007/47/EC) Medical Device Directive
2
4
98/79/EC体外诊断医疗器械指令
Directives
98/79/EC In VitroDiagnostic Medical
Devices
2
5
FDA CFR PART 820 质量体系法规培训
FDA
CFR PART 820 Quality System Regulations Training
3
6
ISO14971 风险管理培训
ISO14971
Risk Management Training
1
7
洁净室建立和管理的培训(ISO14644)
Training
on Establishment and Management of Clean Room (ISO14644)
2
8
过程确认的培训
Training
on Process Validation
1
9
灭菌确认以及过程监控、包装确认的培训
Training
on Sterilization Validation, Process Monitoring and Package Validation
3
10
医疗器械技术文档编制培训
Training
on Preparation of Technical Files for Medical Devices
1
11
质量管理体系内审员培训
Training
for Internal Auditor of Quality Management System
3
12
医疗器械国内法规培训
Training
on Chinese Regulations for Medical Devices
3
13
世界主要经济体医疗器械法规综合培训
Training
on Medical Device Regulations of Major Economies in the World
2
14
医疗器械电气安全和电磁兼容培训(IEC60601)
Training
on Electrical Safety and EMC of Medical Devices (IEC60601)
2
15
软件确认培训
Training
on Software Validation
1
Period
(day)
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