Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on premarket submissions for cybersecurity in medical devices, providing quality system considerations. 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for industry and FDA staff on premarket cybersecurity updates under Section 524B of the FD&C Act. 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 March 12, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical device cyber security: consumer information From Therapeutic Goods Administration (TGA) 🇦🇺 Learn about medical device cyber security and keep your personal health information safe. 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 January 2, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity From International Medical Device Regulators Forum (IMDRF) 🌍 Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity (N73) 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 13, 2023 Other (Public Domain) 0 reuses 0 favorites
Principles and Practices for the Cybersecurity of Legacy Medical Devices From International Medical Device Regulators Forum (IMDRF) 🌍 Principles and Practices for the Cybersecurity of Legacy Medical Devices (N70) Final 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 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical device cyber security information for users From Therapeutic Goods Administration (TGA) 🇦🇺 Find out how to use electronic or software-based medical devices safely. 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 24, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Medical device cyber security guidance for industry From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components. 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 November 24, 2022 Other (Non-Commercial) 0 reuses 0 favorites
MD and IVDMD cybersecurity From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Cybersecurity of MD and IVDMD in your application process 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 September 23, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Guidance Document: Pre-market Requirements for Medical Device Cybersecurity - Summary From Health Canada 🇨🇦 Guidance document is intended to provide advice to manufacturers and regulatory representatives on the practices, responses and mitigation measures, which can improve the cybersecurity of their medical 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 March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry) From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry) 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 November 4, 2020 Other (Public Domain) 0 reuses 0 favorites
Guide No. 38 version 1 of 14/09/2020 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Guide to Cybersecurity Principles and Practices for Medical Devices 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 September 25, 2020 Other (Public Domain) 0 reuses 0 favorites
Principles and Practices for Medical Device Cybersecurity From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/CYBER WG/N60FINAL:2020 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 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software" From Food and Drug Administration (FDA) 🇺🇸 FDA provides guidance on cybersecurity for healthcare organizations using networked medical devices with off-the-shelf software. 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 March 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Guidance document on cybersecurity for networked medical devices containing off-the-shelf software. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance on cybersecurity for medical devices From European Commission 🇪🇺 Guidance on cybersecurity for medical devices, focusing on new technologies. 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
Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for managing cybersecurity in medical devices, addressing labeling, postmarket, premarket, and safety issues. 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 March 7, 2019 Other (Public Domain) 0 reuses 0 favorites
Cyber Security in Medical Devices From Ministry of Health, Labour and Welfare (MHLW) 🇯🇵 Explore the importance of cyber security in medical devices and the measures needed to protect patient data and ensure device integrity. 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 December 8, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
