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13 2023 C 163 06 Commission Guidance on the content and structure of the summary.pdf
2023-9-22 09:48 上传
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12 mdcg_2021-28_Substantial modification of clinical investigation under Medical.pdf
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11 mdcg_2021-20_Instructions for generating CIV-ID for MDR Clinical Investigations.pdf
665.61 KB, 下载次数: 54
10 mdcg_2021-8_Clinical investigation applicationnotification documents.pdf
201.28 KB, 下载次数: 54
09 mdcg_2021-6_Regulation (EU) 2017745 – Questions & Answers regarding clinic.pdf
424.11 KB, 下载次数: 52
08 MDCG 2020-13 Clinical evaluation assessment report template.pdf
966.55 KB, 下载次数: 51
06 MDCG 2020-10 1REV.1 Appendix Clinical investigation summary safety report form.pdf
1.04 MB, 下载次数: 56
06 MDCG 2020-10 1 Appendix Clinical investigation summary safety report form.pdf
261.23 KB, 下载次数: 51
05 MDCG 2020-8 Guidance on PMCF Evaluation Report Template.pdf
680.75 KB, 下载次数: 52
04 MDCG 2020-7 Guidance on PMCF Plan Template.pdf
705.46 KB, 下载次数: 50
03 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices.pdf
860.67 KB, 下载次数: 61
02 MDCG 2020-5 Guidance on clinical evaluation – Equivalence.pdf
1.1 MB, 下载次数: 53
01 MDCG 2019-9 rev 1 Summary of safety and clinical performance.pdf
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liujunpinghk 发表于 2023-9-22 10:23 这不来个个中文版本,,说不过去。。
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