(FD&C Act 524(b)(3)原文:provide to the Secretary a software bill of materials, including commercial,open-source, and off-the-shelf software components;) 与此同时,在FDA 的另外两份指南性材料:Off-The-Shelf (OTS) Software Use in Medical Devices和Cybersecurity for Networked Medical Devices Contain...
此次FDA与MITRE发布的医疗器械网络安全区域事件准备和响应手册(Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook)对于医院和医疗服务机构应对医疗设备网络安全事件时的应急管理能力和事件响应能力起到了补充建议的作用。 目的 本手册提供了一个由利益相关者驱动、开源、可定制的框架,医院和...
此次FDA与MITRE发布的医疗器械网络安全区域事件准备和响应手册(Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook)对于医院和医疗服务机构应对医疗设备网络安全事件时的应急管理能力和事件响应能力起到了补充建议的作用。 目的 本手册提供了一个由利益相关者驱动、开源、可定制的框架,医院和...
Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity: https://www.imdrf.org/documents/principles-and-practices-software-bill-materials-medical-device-cybersecurity OASIS Profile 5: VEX: https://docs.oasis-open.org/csa # 网络安全 # 漏洞分析 # 网络安全技术 # 医...
SBOM Security: Keeping Your Software Supply Chain Accountable Automotive Industrial Medical December 26, 2022 Making Sense of SBOMs and VEX for Healthcare and its Supply Chain • Webinar August 24, 2022 SBOM for Connected Devices: Getting it Right • Reports & Guides View more Mak...
Today’s products and devices are built on a complex combination of open source and third-party software components from a supply chain – in addition to the code created in-house. The increased use of software that isn’t developed in-house means that device and product manufacturers have lit...
Learn about emerging regulations for medical device cybersecurity Related Content All(2)Product(1)Blog Post(1) How Digi ConnectCore MP25 Supports AI/ML and Computer VisionThe integration of AI and machine learning with the power of edge computing supports increasingly advanced high-speed...Read Bl...
FDA Cybersecurity Requirements for Medical Devices The FDA mandates medical device manufacturers to provide an SBOM that inventories commercial, open source, and off-the-shelf software components. This requirement applies for submissions — including 510(k), premarket approval application (PMA), Product...
Vigilant Ops is the only platform that manages the entire Software Bill of Materials (SBOM) lifecycle, from generation to monitoring to management.
In 2023, the IMDRF published “Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity,” a technical document with SBOM-related guidance for both device manufacturers and healthcare delivery organizations. Australian Cyber Security Centre The Australian Cyber Security ...