IMDRF 與美國FDA 皆予以公告的「醫療器材軟體(SaMD)：臨床評估」指引 ... SaMD N10: Software as a Medical Device (SaMD): Key Definitions (2013) ... ... <看更多>
「samd n10」的推薦目錄：
samd n10 在 美國FDA醫療器材軟體臨床評估指引文件之回顧整理 的相關結果
(1) SaMD的定義(SaMD N10指引文件)； (2) SaMD的相關範例(SaMD N12指引文件)； (3) SaMD於風險分級之定位與對風險分級分類的描述說明(SaMD N12指引 ... ... <看更多>
samd n10 在 Software as a Medical Device (SaMD): Key Definitions 的相關結果
This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses on a common definition for when software is considered to be a medical ... ... <看更多>
samd n10 在 Software as a Medical Device (SAMD): Clinical Evaluation - FDA 的相關結果
In 2013, IMDRF's SaMD Working Group released SaMD N10[1] Software as a Medical Device · (SaMD): Key Definitions to create a standard terminology ... ... <看更多>
samd n10 在 What is and what is not a Software as Medical Device (SaMD)? 的相關結果
(IMDRF/SaMD WG/N10 [1]). To help with the development of SaMD, the IMDRF has released guidelines that outline the key considerations:. ... <看更多>
samd n10 在 Software as a Medical Device (SaMD) in the Intelligent Industry 的相關結果
What is Software as a Medical Device (SaMD)?. As per The International Medical Device Regulators Forum (IMDRF) document (IMDRF/SaMD WG/N10 FINAL ... ... <看更多>
samd n10 在 MDS-G23 Guidance on Software as a Medical Device 的相關結果
This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses on a common definition for when software is considered to be a medical ... ... <看更多>
samd n10 在 1 of 3 COVID-19 Medical Device Regulatory Convergence ... 的相關結果
IMDRF/SaMD WG/N10 - Software as a Medical Device (SaMD): Key. Definitions. • IMDRF/SaMD WG/N12 - Software as a Medical Device: Possible ... ... <看更多>
samd n10 在 Software as a Medical Device (SaMD) - Stendard 的相關結果
... a Medical Device Working Group in the IMDRF SaMD WG N10 / Software as a Medical Device: Key Definitions technical document. To be considered as a SaMD, ... ... <看更多>
samd n10 在 Guidance Document: Software as a Medical Device (SaMD) 的相關結果
This document is intended to clarify how SaMD fits into Health ... Device (SaMD): Key Definitions, IMDRF SaMD Working Group N10, 2013 ... ... <看更多>
samd n10 在 IMDRF/SaMD WG/N41FINAL:2017 DOCUMENTO FINAL Título 的相關結果
En 2013, el Grupo de Trabajo del IMDRF para SaMD liberó el documento SaMD N10[1] Software como Dispositivo. Médico (SaMD): Definiciones clave para crear una ... ... <看更多>
samd n10 在 Software como dispositivo médico - Iris Paho 的相關結果
El presente documento titulado IMDRF SaMD WG N10/Software como dispositivo médico2: definiciones clave se centra en una definición común de cuándo un ... ... <看更多>
samd n10 在 Classification of medical device software in the European Union 的相關結果
Technical Document IMDRF/SaMD WG/N10. Software as a Medical Device (SaMD): Key Definitions. Retrieved on 17 May 2023. Johner, C. Prof. ... <看更多>
samd n10 在 Next-Gen Healthcare through SaMD - L&T Technology Services 的相關結果
It consists of analyzed clinical data collected either duringAs per the International Medical Device Regulators Forum (IMDRF) document. (IMDRF/SaMD WG/N10 FINAL ... ... <看更多>
samd n10 在 DOCUMENTO FINAL 的相關結果
Titulo: Software como dispositivo medico (SaMD): definiciones clave. ... Este documento IMDRF SaMD WG N10 / Software como dispositivo médico. ... <看更多>
samd n10 在 国際医療機器規制当局フォーラム (IMDRF) 的相關結果
IMDRF, PROPOSED FINAL DRAFT: Software as a Medical Device (SaMD) Key ... 本文書「IMDRF SaMD WG N10/医療機器としてのソフトウェア: 重要な定義」 は、 SaMD ... ... <看更多>
samd n10 在 Software as a Medical Device (SaMD) - GM-RKB 的相關結果
... the process for clinical evaluation of a SaMD (software with a medical purpose as defined in SaMD N10), as illustrated in Figure 1, to establish that:. ... <看更多>
samd n10 在 無題 的相關結果
Samd n10 https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd WebThe key definitions and terms developed in ... ... <看更多>
samd n10 在 Definition & Classification - bluewalk 的相關結果
Software as a Medical Device (SaMD): Key Definitions (SaMD WG/N10) ... Harmonization Task Force (GHTF) documents, with relevance to SaMD. ... <看更多>
samd n10 在 HealthTech - Shifting Landscapes Series (Part 2): Software as ... 的相關結果
SaMD uses data input to output results which have a medical purpose. ... [1] IMDRF SaMD N10 2013: Software as a Medical Device (SaMD): Key ... ... <看更多>
samd n10 在 医疗器械软件(SaMD) 临床评价_文件 - 搜狐 的相關結果
国际医疗器械监管机构论坛（IMDRF）旨在就临床评价和证明IMDRF/SaMD WG/N10 文件“医疗器械软件(SaMD): 主要定义”(SaMD N10)中所定义的用于医疗用途的 ... ... <看更多>
samd n10 在 Regulatory Frameworks for Development and ... - NCBI 的相關結果
IMDRF Software as a Medical Device (SaMD) Working Group Software as a medical device (SaMD): key definitions. Doc no. IMDRF/SaMD WG/N10 FINAL: ... ... <看更多>
samd n10 在 Top 40 IMDRF Technical Documents for Medical Devices 的相關結果
IMDRF/SaMD WG/N10. Software as a Medical Device (SaMD): Key Definitions. What's in this guidance document? The document provides definitions of ... ... <看更多>
samd n10 在 Software as a Medical Device: FDA Releases Draft Guidance 的相關結果
The FDA draft guidance defines SaMD as “software intended to be used ... as a Medical Device (SaMD): Key Definitions (N10); Software as a ... ... <看更多>
samd n10 在 Software as a Medical Device Clinical Evaluation 的相關結果
Proper understanding, planning, and design of SaMD is essential for approval. ... guidance documents related to SaMD on key definitions (IMDRF/SaMD WG/N10), ... ... <看更多>
samd n10 在 Regulatory Frameworks for Development and Evaluation of ... 的相關結果
Software as a medical device (SaMD): key definitions. Doc no. IMDRF/SaMD WG/N10 FINAL:2013. International Medical Device Regulators Forum (IMDRF) ... ... <看更多>
samd n10 在 IMDRF documents - Regulations.gov 的相關結果
IMDRF/SaMD WG/N10. FINAL:2013. Software as a Medical Device (SaMD): Key Definitions - PDF (119kb). Software as a Medical Device (SaMD): Key ... ... <看更多>
samd n10 在 医疗器械软件(SaMD) 临床评价（一） - 质量人 的相關結果
国际医疗器械监管机构论坛（IMDRF）旨在就临床评价和证明IMDRF/SaMD WG/N10 文件“医疗器械软件(SaMD): 主要定义”(SaMD N10)中所定义的用于医疗用途的 ... ... <看更多>
samd n10 在 The EU Regulatory Environment of Medical Device Software ... 的相關結果
Device” (SaMD), primarily used by ... Software as a Medical Device (SaMD): Application of Quality Management System. IMDRF/SaMD WG/N10 FINAL:2013. ... <看更多>
samd n10 在 IMDRF SaMD WGの活動について - PMDA 的相關結果
Copyright © Pharmaceuticals and Medical Devices Agency, All Rights Reserved. 1. IMDRF SaMD. N10. 2013.12.9. 定義に関する文書. ... <看更多>
samd n10 在 guideline for registration of software as medical device 的相關結果
IMDRF SaMD WG N10 / Software as a Medical Device: Key Definitions b. GHTF/SG1/N70:2011 “Label and Instructions for Use for Medical Devices”. ... <看更多>
samd n10 在 Machine language (AI/ML) Based Soft- ware as medical ... 的相關結果
the AI/ML based SaMD was discussed and the modifications or the updates regulatory ... 21. SaMD N10: Software as a Medical Device (SaMD):. ... <看更多>
samd n10 在 GENERATING EVIDENCE FOR ARTIFICIAL INTELLIGENCE ... 的相關結果
Use-case: Defining intended use for AI-SaMD in cervical cancer screening. 19. 5. Model development and training for clinical evaluation. ... <看更多>
samd n10 在 Proposed new deliverable: FG-AI4H terms and definitions - ITU 的相關結果
2.1.1 Algorithm [IMDRF/SaMD-N41]: a finite set of instructions (or rules) that defines a ... SaMD: Key Definitions (N10); SaMD: Possible Framework for Risk ... ... <看更多>
samd n10 在 Software as a Medical Device (SaMD): Key definitions 的相關結果
IMDRF/SaMD WG/N10 FINAL:2013 Final Document Title: Software as a Medical Device (SaMD): Key definitions Authoring Group: IMDRF SaMD Working Group Date: 9 ... ... <看更多>
samd n10 在 Guide IMDRF : Définitions pour les Intelligences Artificielles DM 的相關結果
IMDRF/SaMD WG/N10 : Logiciel en tant que dispositif médical (SaMD) : Définitions clés (Monde); IMDRF/GRRP WG/N47 : Principes essentiels de ... ... <看更多>
samd n10 在 제22차 IMDRF 이해당사자 포럼(실무그룹) 주요 내용 的相關結果
의료용 소프트웨어(Software as a Medical Device, SaMD) 실무그룹 ... N10 SaMD 주요 용어(Key Definitions) ... N41 SaMD 임상 증거(Clinical Evaluation) ... ... <看更多>
samd n10 在 RegulaBase - QualityCert 的相關結果
IMDRF/SaMD WG/N10 Software as a Medical Device (SaMD): Key Definitions. IMDRF information documents. Statement regarding Use of ISO 14971:2007 "Medical ... ... <看更多>
samd n10 在 移动医疗器械注册技术审查指导原则 的相關結果
[52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical Device（SaMD）：Key Definitions，2013.12.18. [53] IMDRF/SaMD WG/N12 ... ... <看更多>
samd n10 在 Thursday, 25th June 2020 09am to 10.30am (Singapore time ... 的相關結果
Employed by most currently marketed AI-based SaMD. ... Software as a Medical Device (SaMD): Intended to be used for one ... (SaMD N10). ... <看更多>
samd n10 在 Handbook of Artificial Intelligence in Healthcare: Vol 2: ... 的相關結果
... WG/N10:2013 Software as a Medical Device (SaMD): Key Definitions, http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-defini ... ... <看更多>
samd n10 在 Introduction to Medical Software: Foundations for Digital ... 的相關結果
IMDRF/SaMD WG/N10. www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209samd-key-definitions-140901.pdf. [126] International Medical Devices Regulator ... ... <看更多>
samd n10 在 Generating evidence for artificial intelligence-based ... 的相關結果
... SaMD: Key Definitions (N10) • SaMD: Possible Framework for Risk Categorisation and considerations (N12) 2014 • SaMD: Application of Quality Management ... ... <看更多>
samd n10 在 Neurorehabilitation Technology - 第 267 頁 - Google 圖書結果 的相關結果
... Device Identification (UDI) of Medical Devices IMDRF/SaMD WG/N10 FINAL:2013 Software as a Medical Device (SaMD): Key Definitions IMDRF/MC/N39 FINAL:2015 ... ... <看更多>
samd n10 在 下一代医疗——软件医疗设备(SaMD)在智能工业-凯捷比利时 的相關結果
根据国际医疗器械监管机构论坛(IMDRF)文档(IMDRF / SaMD WG N10决赛:2013),软件作为一种医疗设备(SaMD)被定义为软件企业用于一个或多个医疗目的,执行这些目的没有硬件 ... ... <看更多>
samd n10 在 Software as Medical Device | SaMD Development - camensys 的相關結果
Nine Questions for Medical Device Software and SAMD Manufacturer ... IMDRF – N10 SaMD: Key Definitions describe the definitions of key terms. ... <看更多>
samd n10 在 CFDA发布首个关于移动医疗器械的规范文件 - CACLP 的相關結果
[52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical Device（SaMD）：Key Definitions，2013.12.18. [53] IMDRF/SaMD WG/N12 FINAL:2014，Software as a ... ... <看更多>
samd n10 在 Guidelines-for-Medical-Device-Software-Registration-Review ... 的相關結果
Standalone software (SaMD) refers to software that has one or more medical ... [ 68 ] IMDRF/ SaMD WG/N10 FINAL: 2013 , SaMD: Key Definitions [Z] , 2013.12. ... <看更多>
samd n10 在 Rudolf Wagner - LinkedIn 的相關結果
Senior Executive for #DigitalHealth, #AI, #SaMD | Quality & Regulatory. Compliance | Operations, Leadership ... IMDRF, Code IMDRF/SaMD WG/N10 (link below). ... <看更多>
samd n10 在 Avada-consult | LinkedIn 的相關結果
Il s'agit du IMDRF/SaMD WG/N10 : "Software as a Medical Device (SaMD): Key Definitions" Il donne les cas où un logiciel est considéré comme un dispositif ... ... <看更多>
samd n10 在 IMDRFの動向 的相關結果
N10 : Software as a Medical Device: Key Definitions. • RPS Beta Testing Document ... SaMDの定義に関する文書（N10）を最終化（2013年12月）。 ... <看更多>
samd n10 在 附件:移动医疗器械注册技术审查指导原则 的相關結果
改自IMDRF SaMD 工作组关于独立软件的定义。 ... [52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical Device（SaMD）：Key. ... <看更多>
samd n10 在 （局发文式样） - 医疗器械软件注册 的相關結果
[52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical Device（SaMD）：Key Definitions，2013.12.18. [53] IMDRF/SaMD WG/N12 FINAL:2014，Software as a ... ... <看更多>
samd n10 在 Medical Writing 的相關結果
medical device (SaMD) by the International. Medical Device Regulators Forum ... Definitions • EU MDR 2017/745 • IMDRF/SaMD WG/N10: 2013. ... <看更多>
samd n10 在 Final Document. Software as a Medical Device (SaMD): Key ... 的相關結果
This document IMDRF SaMD WG N10/Software as a Medical Device 2 : Key Definitions focuses on a common definition for when software is considered to be a ... ... <看更多>
samd n10 在 CEN / CENELEC Joint Task Force, Software as Medical Devices 的相關結果
CEN/CLC JTF SAMD Purpose. Provide adequate standards to enable consistent application of 93/42/EEC, as amended by 2007/47/EC,. ... <看更多>
samd n10 在 移动医疗器械注册技术审查指导原则 的相關結果
[52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical Device（SaMD）：Key Definitions，2013.12.18. [53] IMDRF/SaMD WG/N12 FINAL:2014，Software as a ... ... <看更多>
samd n10 在 Definitions for Personalized Medical Devices - NEMIUS Group 的相關結果
IMDRF/SaMD WG/ N10 FINAL:2013 Software as a medical device (SaMD): Key. Definitions. ISO/ASTM 52900:2015 Additive manufacturing — General ... ... <看更多>
samd n10 在 소프트웨어 의료기기 제조소의 GMP 운영을 위한 민원인 안내서 ... 的相關結果
O 동 민원인 안내서는 소프트웨어 의료기기(SaMD)를 제조하기 위해 ... 소프트웨어 의료기기 변경(SaMD Changes) : 유지보수 ... (IMDRF/SaMD WG/N10 FINAL:2013). ... <看更多>
samd n10 在 D TV40 Módulo 1 S2 by CIB.org - Issuu 的相關結果
El grupo de trabajo libera el SaMD N10. • SaMD N10: Software como Dispositivo Médico (SaMD) : Definiciones clave. ... <看更多>
samd n10 在 imdrf-tech-151002-samd-qms.pdf | Course Hero - Course Hero 的相關結果
IMDRF/SaMD WG/N23 FINAL: 2015 IMDRF International Medical Device Regulators Forum FINAL ... This is a companion document toIMDRF/SaMD WG/N10andN12documents, ... ... <看更多>
samd n10 在 (PDF) What medical writers need to know about regulatory ... 的相關結果
De nitions • EU MDR 2017/745 • IMDRF/SaMD WG/N10: 2013. (Risk) classi cation I, Im, IIa, IIb, III I, II, III. IMDRF/SaMD WG/N12:2014. ... <看更多>
samd n10 在 海外で進む医療ソフトウェア臨床評価の標準化 - MONOist 的相關結果
なお今回の草案の策定に当たっては、以下のドキュメントを参照している。 SaMD N10 ソフトウェア・アズ・ア・メディカル・デバイス（SaMD）：主要な定義 ... ... <看更多>
samd n10 在 KOLIBRI TF.16.001.003-IFU 的相關結果
considered as SaMD, being Health Software Product (HSP) at the same time ... KOLIBRI HSP is SaMD software in the meaning of IMDRF SaMD WG N10/Software as a ... ... <看更多>
samd n10 在 ГОСТ Р 59766-2021 | Стр. 9 的相關結果
IMDRF/SaMD WG/N10. Software as a Medical Device (SaMD): Key Definitions (Программное обеспечение как медицинское изделие. ... <看更多>
samd n10 在 附件 - 医疗器械 的相關結果
[48] IMDRF/SaMD WG/N10 FINAL:2013, Software as a Medical Device(SaMD): Key Definitions, 2013.12.18. [49] IMDRF/SaMD WG/N12 FINAL:2014, Software as a Medical ... ... <看更多>
samd n10 在 111779.docx - 中国食品药品网 的相關結果
独立软件（SaMD）是指具有一个或多个医疗目的/用途，无需医疗器械硬件 ... [68] IMDRF/SaMD WG/N10 FINAL: 2013, SaMD: Key Definitions[Z], 2013.12. ... <看更多>
samd n10 在 UDI Guidance - Nictiz BITS 的相關結果
IMDRF SaMD WG/N10/FINAL:2013 Software as a Medical Device (SaMD): Key Definitions;. - ISO/IEC 15459-2 – Information technology - Unique ... ... <看更多>
samd n10 在 FDA : projet de guide relatif aux essais cliniques des logiciels ... 的相關結果
Ce document s'applique aux « logiciels dispositifs médicaux » tels que définis dans un autre document de 9 pages de l'IMDRF, référencé IMDRF/SaMD WG/N10 ... ... <看更多>
samd n10 在 Заключительный документ 的相關結果
Изделий опубликовала документ SaMD N10[1] «Программное обеспечение как медицинское изделие: основные определения» (Software as a Medical Device (SaMD):. ... <看更多>
samd n10 在 医疗器械软件技术审查指导原则（第二版征求意见稿） 目录 的相關結果
[94] IMDRF/SaMD WG/N10 FINAL: 2013, Software as a. 1223. Medical Device (SaMD): Key Definitions, 2013.12. 1224. [95] IMDRF/SaMD WG/N12 FINAL: 2014, ... ... <看更多>
samd n10 在 鎖惠吉旗艦店- 淘寶網|Taobao 的相關結果
原裝三菱交流接觸器S-N10 S-N11 S-N12 S-N18S-N20 S-N21 S-N25 ... SAMD山電SD-7311 SD-7312 SD-7100 SD7110 行程開關限位微動開關. ... <看更多>
samd n10 在 (PPT) Software as a Medical Device (SaMD) Application of ... 的相關結果
Slide 1 Software as a Medical Device (SaMD) Application of Quality Management System IMDRF/WG/N23 Proposed Document (PD1)R3 Slide 2 NWIP - Quality ... ... <看更多>
samd n10 在 Machine Learning and Medical Devices Connecting practice ... 的相關結果
Modifications to AI/ML-Based Software as a Medical Device (SaMD) ... effectiveness of their SaMD,” supporting “both FDA and ... IMDRF/SaMD WG/N10. ... <看更多>
samd n10 在 ТК 436 Менеджмент качества и общие аспекты ... 的相關結果
1.10.436-1.004.20. Программное обеспечение как медицинское изделие. Основные термины и определения. Разработка ГОСТ Р Модифицирован (MOD) IMDRF/SaMD WG/N10 ... ... <看更多>
samd n10 在 Imdrf Meet 170919 Canada Presentation Working Group ... 的相關結果
Imdrf Meet 170919 Canada Presentation Working Group Update Samd - Free download ... The necessary level of clinical evidence for SaMD ... (IMDRF N10) System ... <看更多>
samd n10 在 оБ оПределенИИ классов ПоТенЦИальноГо рИска ... 的相關結果
Proposed criteria for Software as a Medical Device (SaMD). The proposed classification of SaMD based ... в документе IMDRF/SaMD WG/N10 [23]. ... <看更多>
samd n10 在 О классификации рисков применения медицинского ... 的相關結果
IMDRF/SaMD WG/N10:2013 Software as a Medical Device: Key Definitions, 9 December 2013. 2. IMDRF/SaMD WG/N12:2014 Software as a Medical Device: Possible ... ... <看更多>
samd n10 在 Ethical aspects of using software with artificial intelligence ... 的相關結果
Rezhim dostupa: https://clck.ru/TUnRQ; IMDRF/SaMD WG/N10:2013. Software as a Medical Device (SaMD): Key Definitions. Rezhim dostupa: https://clck.ru/TxCY7 ... ... <看更多>
samd n10 在 Comparative Analysis of Artificial Intelligence on Medical ... 的相關結果
therapeutic processes, and 'IMDRF SaMD WG N10/Software as a Medical. Device: Key Definitions', which concentrates on a common definition for ... ... <看更多>
samd n10 在 医疗器械软件注册审查指导原则（2022年修订版） - 知乎专栏 的相關結果
独立软件（SaMD）是指具有一个或多个医疗目的/用途，无需医疗器械硬件即可完成自身预期用途，运行于通用计算平台的软件[详见IMDRF/SaMD WG/N10 FINAL: ... ... <看更多>
samd n10 在 Compliance enforcement trends for the health care industry 的相關結果
2013 in the final N10 Guide. The FDA recently posted a ... The term SAMD is supposed to classify all software that is used for medical purposes, ... ... <看更多>
samd n10 在 关于发布移动医疗器械注册技术审查指导原则的通告（2017年 ... 的相關結果
[52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical Device（SaMD）：Key Definitions，2013.12.18. [53] IMDRF/SaMD WG/N12 ... ... <看更多>
samd n10 在 W211 Auxiliary Battery Fuse Location 的相關結果
... pojistek Str 1 - Zadní SAM (N10/2) vlevo vzadu Str 1 - Interiér vlevo. ... N10/1: Driver Signal Acquisition and Actuation Module (SAM-D) N10/2: Rear ... ... <看更多>
samd n10 在 移动医疗器械注册技术审查指导原则 - 体外诊断网 的相關結果
1 改自IMDRF SaMD 工作组关于独立软件的定义。 ... [52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical. ... <看更多>
samd n10 在 奔驰辅助电瓶有什么用 - 汽车百科 的相關結果
... 继电器K67 AIRmatic继电器N10/ 1驾驶员信号接收与控制模块SAM-D N10/2 ... 诊断信号G1-系统主电池感应N10/2-行李箱开关G1/7-辅助电池感应A1-警告 ... ... <看更多>
samd n10 在 Fina al Docu ument - 流通システム開発センター 的相關結果
【--IMDRF SaMD WG/N10/FINAL:2013 Software as a Medical Device (SaMD): Key. Definitions; 】. 【--IMDRF SaMD WG/N10/FINAL:2013 医療機器として ... ... <看更多>
samd n10 在 EU MEDICAL DEVICE LEGISLATION - COCIR 的相關結果
Figure 9 Classification Rule 11§1 is based on the IMDRF SaMD risk framework. ... IMDRF N10 Software as a Medical Device (SaMD): Key Definitions. ... <看更多>
samd n10 在 기계학습 가능 의료기기: 주요 용어 및 정의 的相關結果
IMDRF/SaMD WG/N10 FINAL : 2013 Software as a Medical Device. (SaMD): Key Definitions. · IMDRF/GRRP WG/N47 : 2018 Essential Principles of ... ... <看更多>
samd n10 在 什么是移动医疗器械？CFDA发布《移动医疗器械注册技术审查 ... 的相關結果
[52] IMDRF/SaMD WG/N10 FINAL:2013，Software as a Medical Device（SaMD）：Key Definitions，2013.12.18 [53] IMDRF/SaMD WG/N12 ... ... <看更多>
samd n10 在 ГОСТ Р 59766-2021 Программное обеспечение как ... 的相關結果
Основные подходы к категорированию риска" (IMDRF/SaMD WG/N12 FINAL:2014 ... Medical Device (SaMD)], его определение приведено в документе IMDRF/SaMD WG/N10. ... <看更多>
samd n10 在 Программное обеспечение как медицинское изделие 的相關結果
медицинских устройств. Разработаны и приняты 4 базовых документа: • IMDRF/SaMD WG/N10:2013 Software as a Medical Device: Key Definitions. ... <看更多>
samd n10 在 Advancing Regulatory Science With Computational Modeling ... 的相關結果
4. International Medical Device Regulators Forum. Final Guidance, Software as a Medical Device, IMDRF/SaMD WG/N10 FINAL. ... <看更多>
samd n10 在 W211 Auxiliary Battery Fuse Location 的相關結果
Auxiliary Battery: G2: Alternator: K57/2: Auxiliary Battery Relay: K67: ALRmatic Relay: N10/1: Driver Signal Acquisition and Actuation Module (SAM-D) N10/2: ... ... <看更多>
samd n10 在 April 29, 2022 - Connected Health Initiative 的相關結果
Modifications to AI/ML-Based Software as a Medical Device (SaMD) ... IMDRF/SaMD WG/N10. SaMD: Key Definitions. IMDRF/SaMD WG/N12. ... <看更多>
samd n10 在 Software as a Medical Device (SaMD): Key definitions 的相關結果
This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses on a common definition for when software is considered ... ... <看更多>