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Thought Leadership

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.

blog img Automatic External Defibrillator
Case Studies

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.

blog img Surgical Robot System
Case Studies

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.

blog img Home Renal Dialysis System
Case Studies

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.

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