Combined studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Document covers various studies, focusing on clinical trials. 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Performance studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses performance studies, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical investigations From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical investigations, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Announcements From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Various announcements on clinical trials, clinical investigation etc. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic medical devices - Requesting authorization for a performance study From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure In vitro diagnostic medical devices - Requesting authorization for a performance study 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 August 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA plans and reports From Therapeutic Goods Administration (TGA) 🇦🇺 Browse our corporate business plans, performance frameworks and other corporate reports. 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 August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 15: Principles applying to IVD medical devices only From Therapeutic Goods Administration (TGA) 🇦🇺 Principle 15 covers elements that apply to IVD medical devices. Manufacturers should hold evidence of performance evaluation studies to meet the requirements. 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 August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Quality, safety, and performance requirements for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Medical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements. 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 July 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guiding principles: Predetermined change control plans for machine learning-enabled medical devices From Health Canada 🇨🇦 FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans, drawing upon GMLP guiding principles, particularly stating that deployed models are monitored for performance and re-training risks are managed. 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 July 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Principle 5: Medical devices not to be adversely affected by transport or storage From Therapeutic Goods Administration (TGA) 🇦🇺 Principle 5: A medical device must be designed, produced and packed in a way that ensures that the characteristics and performance of the device. 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 July 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical performance requirements and risk mitigation strategies for HIV tests From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations. 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 June 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic medical devices - Performance studies vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure In vitro diagnostic medical devices - Vigilance of performance studies 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 June 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,… 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 June 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 898 Performance Standard for Electrode Lead Wires and Patient Cables From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Performance Standard for Electrode Lead Wires and Patient Cables" under 21 CFR Chapter I Subchapter H. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
COVID-19 testing in Australia: information for health professionals From Therapeutic Goods Administration (TGA) 🇦🇺 Find information on the different types of COVID-19 tests and how we assess them and monitor their performance. 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 May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Reporting of serious adverse events and device defects in performance studies with IVDs From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 28, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Performance studies with non-CE-marked in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Performance studies with non-CE-marked in vitro diagnostic medical devices 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 April 30, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) 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 April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 From European Commission 🇪🇺 Document discusses safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. 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 July 9, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Medical devices reforms From Therapeutic Goods Administration (TGA) 🇦🇺 The Medical Devices Reforms aim to enhance the safety, performance, and quality of medical devices in Australia and focus on patient safety. 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 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites