Cybersecurity Compliance for Connected Devices – FDA, CRA, PSTI & New Engineering Burdens | MedTech
Автор: MedTech Leading Voice - Webinars
Загружено: 2025-07-24
Просмотров: 25
In this expert-led MedTech webinar, Mark Omo (Marcus Engineering) and Chris Gammell (Golioth) break down the rising complexity of cybersecurity regulations for connected medical and health devices.
From the FDA’s Section 524B to the EU CRA and UK PSTI, the session covers engineering requirements around patchability, access control, logging, authentication, and integrity—and how to design with these in mind before a 510(k) update or CE marking submission.
Case studies including the Abbott pacemaker recall, Medtronic MiniMed pump, and HIKVision firmware exploit highlight the real-world impact of poor compliance planning.
Chapters:
(0:06) – What Cybersecurity Compliance Means for Engineers
(4:11) – FDA Definition of a Cyber Device
(10:28) – 5 Engineering Requirements: Patchability to Integrity
(16:20) – EU CRA, UK PSTI & U.S. Cyber Trust Mark
(24:27) – What Counts as “Connected” & Why It Matters
(30:31) – Golioth’s Architecture for Secure OTA
(33:13) – Case Study: Abbott Pacemaker Recall
(38:35) – Case Study: Verta Camera Breach
(43:26) – Case Study: Medtronic MiniMed Pump
(48:21) – Case Study: CMS800 Access Control Failure
(53:23) – Case Study: HIKVision Firmware Backdoor
(56:36) – Best Practices for End-to-End Integrity
(1:02:10) – Wrap-Up & Call to Action
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