Search results with tag "Imdrf"
Proposed document: Software as a Medical Device ... - IMDRF
imdrf.orgIMDRF/SaMD WG (PD1)/N23R3 3 65 Preface 66 67 The document herein was produced by the International Medical Device Regulators Forum 68 (IMDRF), a voluntary group of medical device regulators from around the world.
Software as a Medical Device (SaMD): Key definitions - IMDRF
www.imdrf.orgIMDRF/SaMD WG/N10FINAL:2013 _____ 2.0 Scope . This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses
Final Document: Software as a Medical Device (SaMD ...
www.imdrf.orgThe IMDRF has acknowledged that software is an increasingly critical area of healthcare product development and has developed a series of documents concerning the definition, the categorization, and the application of quality systems principles of SaMD. In 2013, IMDRF’s SaMD Working Group released SaMD N10 [1] Software as a Medical Device
Update on Medical Device and IVD Regulation in Japan - …
www.pmda.go.jpperformance of SaMD using AI ... UDI based on GHTF/IMDRF 2. Conduct educational sessions for industry to sufficiently train the new regulation / requirements. • e.g. Seminar, Q&A, Consultation 3. Coordinated approach for the introduction of the new regulation / requirements.
令和2年5月13日 厚生労働省医薬・生活衛生局医療機器審査管 …
www.mhlw.go.jpしい。その他の関連文書である「IMDRF/SaMD WG/N12 FINAL: 2014」の9.3 項では、 安全を考慮する際の情報セキュリティの重要性について記載されており、医療機器ソフ トウェア（Software as Medical Device：SaMD）の情報セキュリティに影響する幾つかの
Presentation: Regulation of Medical Devices: a ... - …
imdrf.orgAlexandre Lemgruber IMDRF Meeting Tokyo, March 2015 Regulation of Medical Devices: a Regional approach
GHTF SG5 Key Definitions and Concepts - IMDRF
www.imdrf.orgClinical Evidence – Key Definitions and Concepts Study Group 5 Proposed Document SG5(PD)N1R7 April 26, 2006 Page 5 of 8 Given the complexity of the medical devices milieu, the assessment of what is acceptable clinical
Global Medical Device Nomenclature (GMDN) - WHO
www.who.intGlobal acceptance? GHTF (now IMDRF) proposes GMDN for UDI EC proposes GMDN for the EUDAMED (market surveillance database) EUCOMED supports the use of GMDN in meeting the needs of European manufacturers
IMDRF/SaMD WG/N23 FINAL: 2015 - Software as a Medical ...
www.imdrf.orgThe IMDRF/SaMD WG/N12 document also highlights the use of quality management as a general consideration towards the safety, effectiveness, and performance of SaMD and as key to ensuring the predictability and quality of SaMD. Quality Management System (QMS) principles, for many industrial sectors, can be found in the
IMDRF - Presentation - Definition and regulation …
www.imdrf.orgGerman Medicines Manufactures´ Association . IMDRF-3 / 20 March 2013 / Dr. Artur Menzel / BAH Germany . Definition and regulation in terms of …
IMDRF Stakeholders Meeting
www.imdrf.org1. What is DITTA? • DITTA is the Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association • DITTA is a global organization representing Industry Associations of Manufacturers around the world. • Member companies manufacture: medical x-ray equipment; computed tomography (CT)
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