imdrf
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IMDRF/SaMD WG/N12FINAL:2014
18 sep 2014 This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of ... |
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Software as a Medical Device (SaMD): Key definitions
9 dec 2013 The document herein was produced by the International Medical Device Regulators Forum. (IMDRF) a voluntary group of medical device regulators ... |
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Final Document: Software as a Medical Device (SaMD): Clinical
21 sep 2017 The International Medical Device Regulators Forum (IMDRF) seeks to establish a common and converged understanding of clinical evaluation and ... |
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GHTF SG3 - Quality management system –Medical Devices
The document herein was produced by the Global Harmonization Task Force which is comprised of representatives from medical device regulatory agencies and |
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IMDRF Strategic Plan 2021 - 2025
25 sep 2020 The mission1 of the International Medical Device Regulators Forum (IMDRF) is to strategically accelerate international medical device regulatory ... |
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Imdrf pmd wg/n49 final: 2018
18 okt 2018 The document herein was produced by the International Medical Device Regulators Forum. (IMDRF) a voluntary group of medical device regulators ... |
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IMDRF Standard Operating Procedures
19 dec 2022 As an Affiliate Member the regulatory authority will participate in IMDRF by attending “open” meetings and using IMDRF documents in part or in ... |
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UDI guidance: Unique Device Identification (UDI) of medical devices
9 dec 2013 This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of ... |
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IMDRF/SaMD WG/N23 FINAL: 2015 - Software as a Medical Device
2 okt 2015 The IMDRF/SaMD WG/N12 document also highlights the use of quality management as a general consideration towards the safety effectiveness |
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IMDRF: Methodological Principles in the Use of International
16 mrt 2017 This methodological document also builds on the IMDRF Common Data Elements (CDE) for Medical Device Identification document. The CDE effort ... |
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IMDRF/SaMD WG/N12FINAL:2014
18 sept. 2014 Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group ... produced by the International Medical Device Regulators Forum. |
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Software as a Medical Device (SaMD): Key definitions
9 déc. 2013 IMDRF/SaMD WG/N10FINAL:2013. Final Document. Title: Software as a Medical Device (SaMD): Key Definitions. Authoring Group: IMDRF SaMD ... |
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IMDRF/SaMD WG/N23 FINAL: 2015 - Software as a Medical Device
2 oct. 2015 The IMDRF/SaMD WG/N12 document also highlights the use of quality management as a general consideration towards the safety effectiveness |
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Final Document: Software as a Medical Device (SaMD): Clinical
21 sept. 2017 The International Medical Device Regulators Forum (IMDRF) seeks to establish a common and converged understanding of clinical evaluation and ... |
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UDI guidance: Unique Device Identification (UDI) of medical devices
IMDRF UDI Working Group. Date: 9 December 2013. Despina Spanou IMDRF Chair. This document was produced by the International Medical Device Regulators Forum |
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IMDRF Strategic Plan 2021 - 2025
25 sept. 2020 IMDRF International Medical. Device Regulators Forum. FINAL DOCUMENT. IMDRF Strategic Plan 2021 - 2025. IMDRF Management Committee. |
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Principles and Practices for Medical Device Cybersecurity
18 mars 2020 IMDRF. IMDRF/CYBER WG/N60FINAL:2020. International Medical. Device Regulators Forum. FINAL DOCUMENT. Principles and Practices for Medical ... |
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Imdrf pmd wg/n49 final: 2018
18 oct. 2018 IMDRF/PMD WG/N49 FINAL:2018. Final Document. Title: Definitions for Personalized Medical Devices. Authoring Group: IMDRF Personalized ... |
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MDCG 2021-10 - The status of Appendixes E-I of IMDRF N48 under
MDCG 2021-10. Page 1 of 3. MDCG 2021-10 - The status of. Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices. May 2021. |
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IMDRF MDCE WG/N56FINAL:2019 (formerly GHTF/SG5/N2R8:2007)
IMDRF SaMD WG/N41:2017 Software as a Medical Device (SaMD): Clinical Evaluation. IMDRF Registry WG/N33FINAL:2016 Principles of International System of |
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IMDRF - MassMEDIC
The mission of the International Medical Device Regulators Forum (IMDRF) is to strategically accelerate international medical device regulatory convergence to |
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Table des matières (TdM) de lIMDRF – Nouveau format de
L'International Medical Devices Regulators Forum (IMDRF) est un groupe formé d'organismes de réglementation des instruments médicaux du monde entier |
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IMDRF terminologies for categorized Adverse Event Reporting (AER
18 mar 2020 · Reporting (AER): terms, terminology structure and codes Authoring Group: IMDRF Adverse Event Terminology Working Group Date: 18 March |
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IMDRF Terms of Reference, 27 July 2018 - International Medical
27 juil 2018 · YUAN Lin，IMDRF Chair This document was produced by the International Medical Device Regulators Forum There are no restrictions on the |
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IMDRF Review of the NCAR Exchange Program
DG Health and Consumer Protection Chair of the IMDRF WG on NCAR Review WHO 2nd Global Forum Medical Devices Geneva, 22-24 November 2013 |
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Update on COVID-19 in vitro diagnostics listed by National
8 avr 2020 · The links provided below present information on IVDs authorized for use in the International Medical Device Regulators Forum (IMDRF)1 |
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IMDRF UDI Application Guide Overview - GS1
27 oct 2018 · IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational |
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IMDRF Standard Operating Procedures - NEMIUS Consulting
Date: 21 March 2019 Elena M Astapenko, IMDRF Chair This document was produced by the International Medical Device Regulators Forum There are no |
