The Cyber and the Science of Secure Medical Systems
We founded an industry to help medical device and healthcare software companies bring secure, compliant, and future-ready products to market—with the rigor of scientists and the foresight of engineers.
We Know Medical Systems
Harbor Labs is a seasoned team of computer scientists and system security engineers who specialize in securing connected medical technologies. From singular devices to entire hospital networks, we combine deep technical expertise with regulatory fluency to deliver clarity, resilience, and speed at every stage of the product lifecycle.
We don’t just test—we think, engineer, and advise with precision.
See how we apply scientific discipline to systems development, certification, and in-market protection.
Meet the people behind the work: a team of experts trusted by the industry’s most innovative companies.
Trusted by Organizations
Built for the Full Product Lifecycle
Compliance isn’t a finish line. It’s part of a larger discipline: making medical technologies secure, resilient, and ready for the real world. We can guide you through the full journey—or step in during the phases where you need the most support.
Systems
Development
Certification &
Go-to-Market
In-Market
Systems Development
Built-In Resilience
Security starts with architecture. We help you design systems that are defensible from the ground up—hardening firmware, securing interfaces, and aligning with cybersecurity frameworks from the first commit forward.
Home Renal Dialysis System
Developing a secure connection from a patient’s home dialysis system to the clinical cloud, ensuring compliance with patient safety and privacy standards.
Certification & go-to-market
A Clear Path to Launch
We support FDA cybersecurity submissions across 510(k), PMA, and Q-Sub pathways—helping your team build the technical narrative and documentation regulators expect. From early strategy to final clearance, we align your work with current expectations to reduce friction and avoid delays.
Wearable ECG Device
Regulatory support for a wearable ECG device, including cybersecurity documentation, SDLC procedures, formal testing, and tailored eSTAR submission for FDA premarket guidance.
In-Market
Enduring Security
Cybersecurity doesn’t end at launch. We support post-market surveillance, vulnerability management, and system updates—so your product stays resilient, compliant, and trusted long after it reaches the field.
Surgical Robotics System
Remediating a critical third-party vulnerability in surgical robotics, ensuring 510(k) readiness and safeguarding clinical operations from cybersecurity risks.
Faster timelines.
More comprehensive reviews. Precise custom solutions.
How We Get You There
Specialized expertise across cybersecurity, compliance, and engineering—so you can move from idea to impact with clarity and confidence.
Cybersecurity Testing
We don’t just find vulnerabilities—we help you understand them. From risk assessments to penetration testing, we apply scientific rigor to uncover real-world weaknesses and provide actionable insight.
Regulatory Support
Our team works directly with your engineers and regulatory leads to develop cybersecurity documentation that stands up to scrutiny. We bring clarity, structure, and speed to even the most complex submissions.
Cyber Engineering
We help you build defensible systems from the inside out. Whether you’re designing secure firmware, architecting a hardened interface, or developing a custom toolchain, we bring deep systems expertise to the table.
Harbor Labs’ vast experience, technical knowledge, dedication, professionalism, and great attention to detail proved to be an invaluable asset for us … by not only identifying potential vulnerabilities but also suggesting highly creative and innovative ideas to solve them. Highly recommended!”
Cristian Luciano, PhD
VP, R&D/Digital Surgery, Surgalign Spine Technologies