Why FDA Rejects the Cybersecurity Content of Regulatory Submissions
Harbor Labs Chief Scientist Dr. Avi Rubin identifies some of the most common reasons why the FDA rejects the cybersecurity content of regulatory submissions.
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Automatic External Defibrillator
As part of our Medical Device Security services, HarborLabs assisted a leading manufacturer to help resolve a security issue that was impeding regulatory approvals and corporate business objectives. Learn more about this case and our services.
Surgical Robot System
As part of our Medical Device Security services, HarborLabs was contracted by a manufacturer of a specialized surgical robotics system to conduct a pre-market cyberthreat analysis in support of their 510(k) submission. Learn more about this case and our services.
Home Renal Dialysis System
As part of our Medical Device Security services, a major manufacturer of kidney dialysis systems engaged with HarborLabs to extend the functionality of their line of portable dialysis machines. Learn more about this case and our services.
Medical Systems and Third-Party Smart Devices
As more medical devices leverage phones and other consumer devices, are they introducing more risk to patients? We’ll go inside a conceptual hack and explore the impact of the crossover between unregulated third-party devices and smart medical devices.