|+V4.0 1.3 MB
| | Software Document_V4.0.doc 404.0 KB
| | Risk Management Report_V4.0.doc 719.0 KB
| | Lumenis Risk Analysis Matrix Template.xls 176.0 KB
|+V3.0 1.2 MB
| | Risk Management Plan_V3.0.doc 465.0 KB
| | Annex 2. Software Document_V3.0.doc 350.0 KB
| | Annex 1. Risk Analysis Report_V3.0.doc 418.0 KB
|+V1.0 506.0 KB
| | Risk Management Report V1.0 Template-2 (Oxygen Concentrator).doc 268.0 KB
| | Risk Management Report V1.0 Template-1 (Electronic Thermometer).doc 238.0 KB
|+RM 5.0 4.6 MB
| Software Document_V5.0.doc 1.8 MB
| RM Result Table_V5.0.doc 1.2 MB
| Risk Management Procedure_V5.0.doc 480.0 KB
| Risk Analysis Report_V5.0.pdf 554.0 KB
| Risk Analysis Report_V5.0.doc 611.0 KB
| Note.txt 406 Byte
+学习资料 28.3 MB
| 风险管理技术.doc 1.4 MB
| 风险管理过程(普通版).pdf 723.0 KB
| YYT0316-200X (ISO14971-2007) 医疗器械-风险管理对医疗器械的应用(报批稿).pdf 1.9 MB
| YYT0316-2003 (ISO14971-2000)医疗器械风险管理对医疗器械的应用.pdf 3.1 MB
| Risk management report (Example -1).rtf 8.3 MB
| Risk management report (Example -1).doc 1.4 MB
| Lecture-1 Intro to ISO 14971 - Milan Meeting.ppt 1.0 MB
| ISO_14971_2007_Checklist - template.doc 308.0 KB
| ISO 14971_2007.pdf 1.3 MB
| ISO 14971_2000.pdf 586.0 KB
| iec60601_1e_TH1_CH1.rtf 4.7 MB
| Checklist RMF IEC 60601-1 ed 3 rev. June 2011_z1.doc 303.0 KB
| Checklist PEMS, Clause 14, rev.1.doc 108.0 KB
| Appendix B for RISK MANAGEMENT.doc 194.0 KB
| AAMI ES60601-1_2005+A1+A2.pdf 3.1 MB
| 2007版医疗器械风险管理标准的主要变化.doc 29.0 KB
+RM 700.0 KB
Risk Analysis Form.doc 116.0 KB
ISO14971-2007中文.pdf 555.0 KB
2007版医疗器械风险管理标准的主要变化.doc 29.0 KB
Risk Management风险分析.zip
(19.22 MB, 需要: RMB 29 元)


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