18 sep 2014 This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of ...
9 dec 2013 The document herein was produced by the International Medical Device Regulators Forum. (IMDRF) a voluntary group of medical device regulators ...
21 sep 2017 The International Medical Device Regulators Forum (IMDRF) seeks to establish a common and converged understanding of clinical evaluation and ...
The document herein was produced by the Global Harmonization Task Force which is comprised of representatives from medical device regulatory agencies and
25 sep 2020 The mission1 of the International Medical Device Regulators Forum (IMDRF) is to strategically accelerate international medical device regulatory ...
18 okt 2018 The document herein was produced by the International Medical Device Regulators Forum. (IMDRF) a voluntary group of medical device regulators ...
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 ...
9 dec 2013 This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of ...
2 okt 2015 The IMDRF/SaMD WG/N12 document also highlights the use of quality management as a general consideration towards the safety effectiveness
16 mrt 2017 This methodological document also builds on the IMDRF Common Data Elements (CDE) for Medical Device Identification document. The CDE effort ...
18 sept. 2014 Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group ... produced by the International Medical Device Regulators Forum.
9 déc. 2013 IMDRF/SaMD WG/N10FINAL:2013. Final Document. Title: Software as a Medical Device (SaMD): Key Definitions. Authoring Group: IMDRF SaMD ...
2 oct. 2015 The IMDRF/SaMD WG/N12 document also highlights the use of quality management as a general consideration towards the safety effectiveness
21 sept. 2017 The International Medical Device Regulators Forum (IMDRF) seeks to establish a common and converged understanding of clinical evaluation and ...
IMDRF UDI Working Group. Date: 9 December 2013. Despina Spanou IMDRF Chair. This document was produced by the International Medical Device Regulators Forum
25 sept. 2020 IMDRF International Medical. Device Regulators Forum. FINAL DOCUMENT. IMDRF Strategic Plan 2021 - 2025. IMDRF Management Committee.
18 mars 2020 IMDRF. IMDRF/CYBER WG/N60FINAL:2020. International Medical. Device Regulators Forum. FINAL DOCUMENT. Principles and Practices for Medical ...
18 oct. 2018 IMDRF/PMD WG/N49 FINAL:2018. Final Document. Title: Definitions for Personalized Medical Devices. Authoring Group: IMDRF Personalized ...
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.
IMDRF SaMD WG/N41:2017 Software as a Medical Device (SaMD): Clinical Evaluation. IMDRF Registry WG/N33FINAL:2016 Principles of International System of