))
12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman
Manage episode 383696384 series 3408784
内容由biologicsconsulting提供。所有播客内容（包括剧集、图形和播客描述）均由 biologicsconsulting 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品，您可以按照此处概述的流程进行操作https://zh.player.fm/legal。
Security from cyberattack for medical devices is paramount. And the FDA wants you to have a plan for it. Becky Ditty and Donna-Bea Tillman tell you how to be prepared.
Guidance documents:
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions - Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices - Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff (related to the requirements per the Consolidated Appropriations Act, 2023)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-devices-containing-shelf-ots-software
Playbook for Threat Modeling devices
https://www.mitre.org/publications/technical-papers/playbook-threat-modeling-medical-devices
15集单集
分享
