MDCG 2020-7 PMCF plan医疗器械上市后临床随访计划 下载积分: 600 内容提示: 1 Ref. Ares(2020)2214397 - 24/04/2020 Medical Device Medical Device Coordination Group Document MDCG 2020-7 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of...
2020年11月2日 2020年4月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG) MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template 和MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation R…
MDCG 2020-7 上市后临床随访 (PMCF) 计划模板中文版.docx,医疗疗 医疗疗器械 医疗器械协调组织文件 MDCG 2020-7 MDCG 2020-7 MDCG 2020-7 上市后临床随访 (PMCF) 计划模板制造商和公告机构指南 2020 年 4 月 本文件已得到根据法规 (EU) 第 103 条设立的医疗器械协调组 (MDCG
MDCG 2020-7 is a document that provides guidance on the activities related to Post-Market Clinical Follow-up (PMCF) for medical devices。The purpose of this document is to provide a XXX with the Medical Device n (MDR) XXX (IVDR). n C。Activities related to PMCF: general and specific me...
MDCG 2020-7 PMCF计划模板Ref. Ares(2020)2214397 - 24/04/2020 Medical Device CoordinationGroupDocumentMDCG2020-7 ThisdocumenthasbeenendorsedbytheMedicalDeviceCoordinationGroup(MDCG)establishedbyArticle103ofRegulation(EU) 2017/745. The MDCG is composed of representatives of all Member States and it is...
MDCG 2020-7 上市后临床随访计划模板 PMCF Plan Template.pdf,Ref. Ares(2020)2214397 - 24/04/2020 Medical Device Medical Device Coordination Group Document MDCG 2020-7 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers
内容提示: MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies 上市后临床跟踪(PMCF )计划模板 给制造商和公告机构的指南 April 2020 2020 年年 04 月 This document has been endorsed by the Medical Device Coordination Group (MDCG) ...
MDCG 2020-7 PMCF计划的模板 类别：临床调查和评估 出版日期：2020年4月 本指南包括指导制造商编制PMCF计划须遵守的欧盟MDR要求的模板。该指南适用于所有需执行PMCF的制造商,可使用该指南以符合欧盟MDR的方式编制PMCF计划。第24名 MDCG2020-6遗留器械充分临床证据要求 类别：临床调查和评估 出版日期：2020年4月 本...
Medical Device Coordination Group Document MDCG 2020-7 5 Post-market clinical follow-up plan Template PMCF plan number: PMCF plan date: PMCF plan version: Revision history Rev Revision date Description of change Revised by Section A. Manufacturer contact details ...
资料介绍 欧盟管理委员会发布的MDR框架下的PMCF上市后临床评价计划模板 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies资料大小: 695.89KB 所属类别: 法规标准 更新日期: 2021-02-04 适用行业: 医疗器械 ...