Transparency for machine learning-enabled medical devices: Guiding principles From Health Canada π¨π¦ Guiding principles for good medical device machine learning practice developed by Health Canada, the US Food and Drug Administration and the United Kingdomβs Medicines and Healthcare products Regulatory Agency. 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
Guiding principles: Predetermined change control plans for machine learning-enabled medical devices From Health Canada π¨π¦ 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
Machine learning medical devices: transparency principles From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Guidelines for communicating clear and relevant information about machine learning-enabled medical devices. 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 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Draft Pre-market guidance for machine learning-enabled medical devices: Share your views From Health Canada π¨π¦ Outlining the purpose of the guidance document for machine learning-enabled 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 November 21, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes. 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 24, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) π°π· This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS)β¦ 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 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
Machine Learning-enabled Medical Devices: Key Terms and Definitions From International Medical Device Regulators Forum (IMDRF) π Technical Document: IMDRF/AIMD WG/N67 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 May 9, 2022 Other (Public Domain) 0 reuses 0 favorites