EUDAMED β Technical documentation From European Commission πͺπΊ This document provides technical documentation related to EUDAMED, a system for the exchange of information on medical devices within the EU. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) π°π· This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyzeβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on sampling of devices for the assessment of the technical documentation From European Commission πͺπΊ Guidance on sampling of devices for technical documentation assessment, focusing on Notified bodies. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Handbook for Preparation of Summary Technical Documentation Submitted in Applications for Marketing Approval for Medical Devices From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PFSB/ELD/ OMDE Notification No. 0216003 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on February 16, 2005 Other (Public Domain) 0 reuses 0 favorites