EUDAMED – Machine-to-machine From European Commission 🇪🇺 This document provides information on the EUDAMED system and its machine-to-machine communication capabilities for efficient data exchange in healthcare. 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
EUDAMED – Basic concepts From European Commission 🇪🇺 This document provides an overview of the basic concepts related to EUDAMED, offering insights into its key components and functionalities. 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
Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device From Health Canada 🇨🇦 Health Canada has updated the Guidance on how to interpret ‘significant change’ of a medical device. This guidance: • helps manufacturers determine when a change made to a device is significant • explains the concepts that manufacturers must apply when making this determination • provides many… 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 February 7, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices From European Commission 🇪🇺 This document provides an overview of vigilance terms and concepts in the EU regulation on medical devices, focusing on post-market surveillance. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on the concept and principles of the least burdensome provisions in premarket regulations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance on clinical evaluation – Equivalence From European Commission 🇪🇺 This document provides guidance on clinical evaluation, specifically focusing on the concept of equivalence. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guide No. 29 version 1 of 17/12/2019 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Medical Devices Clinical Evidence Guide - Concepts and Definitions Metadata quality: Metadata quality: Data description empty Files documented 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 December 30, 2019 Other (Public Domain) 0 reuses 0 favorites
Clinical Evidence - Key Definitions and Concepts From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF MDCE WG/N55FINAL:2019 (formerly GHTF/SG5/N1R8:2007) Metadata quality: Metadata quality: Data description empty Files documented 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 October 10, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Custom Devices; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-24438. The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the… 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 October 12, 2016 Other (Public Domain) 0 reuses 0 favorites
What is a drug-device consultation? From Health Products Regulatory Authority (HPRA) 🇮🇪 A brief overview of drug-device consultations concept. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
What is a UDI code? From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Learn about the concept of UDI codes. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on February 7, 2024 Other (Public Domain) 0 reuses 0 favorites
Easy to understand medical device concepts From Ministry of Food and Drug Safety (MFDS) 🇰🇷 A document discussing simple and clear explanations of medical device concepts. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on February 7, 2024 Other (Public Domain) 0 reuses 0 favorites