Medical Device Manufacturer Must Do’s for Cybersecurity
Harbor Labs Director of Medical Security Dr. Mike Rushanan provides a comprehensive outline of the cybersecurity must-do’s necessary to meet regulatory approval. Based on years of experience working with the FDA and other regulatory bodies, Dr. Rushanan’s blog provides insights into the common pitfalls that can disqualify or delay regulatory approvals.
DIY Diabetics and FDA Policy
Technology is putting more control into patients’ hands and expanding their access to data. But how far is too far? HarborLabs’s Director of Medical Security provides his view of DIY technology regarding diabetes-care technology.
New FDA Guidance On WiFi-Managed Infusion Pumps Is Cybersafe And Cybersecure
HarborLabs’ CEO, Nick Yuran, was recently interviewed about misconceptions and concerns around the FDA’s new policies on wireless management of infusion pumps. Here are his thoughts regarding the interview and the overall risks involved.
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.