需要金币:*** 金币(10金币=人民币1元) mdcg_2020-6 关于传统设备的充分临床证据的指导.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Medical Device Medical Device Coordination Group Document MDCG 2020-6 MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medic...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representat...
Medical Device Medical Device Coordination Group Document MDCG 2019-9 Rev.11(24)MDCG 2019-9 Rev.1Summary of safety and clinical performanceA guide for manufacturers and notified bodies March 2022This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article ...
免费在线预览全文 Medical Devices Medical Devices Coordination Group Document MDCG 2020-13 MDCG 2020-13 Clinical evaluation assessment report template July 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. Th...
MDCG 2022-21 定期安全更新报告(PSUR)指南.pdf,Medical Devices Medical Device Coordination Group Document MDCG 2022-21 MDCG 2022- 2021 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR) December 2022 This document h
1 Medical Devices Medical Device Coordination Group Document MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the ...
Medical Device Ref. Ares(2019)6021482 - 27/09/2019 Medical Device Coordination Group Document MDCG 2019-9 MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies August 2019 This document has been endorsed by the Medical Device Coordination Group (MD...
MDCG 2020-3 重大变更和附件指南.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020 - 3 MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by cer
MDCG 2020-3 重大变更和附件指南.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020 - 3 MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by cer
Medical Device Medical Device Coordination Group Document MDCG 2019-9 MDCG 2019-9 Summary of safety and clinical performance 安全性和临床表现总结 A guide for manufacturers and notified bodies 制造商和公告机构指南 August 2019 This document has been endorsed by the Medical Device Coordination Group (...