))
12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman
Manage episode 383696384 series 3408784
Kandungan disediakan oleh biologicsconsulting. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh biologicsconsulting atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.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 episod
Kongsi
