Embedded. Connected.
Tested with Precision.
We apply rigorous, real-world testing to embedded software and firmware systems—uncovering security gaps before they reach the field.
Software & Firmware Testing Capabilities
From pre-submission strategy to postmarket response, Harbor Labs supports medical device and software companies through every regulatory milestone. Our team combines cyber science and regulatory insight to help you prepare stronger submissions, navigate evolving expectations, and maintain security long after launch. Whether you’re building documentation for FDA clearance or managing a fielded product, we bring clarity, precision, and long-term resilience to the work that matters most.
Regulatory Strategy
We help you plan your submission from the ground up—bringing deep experience with 510(k), PMA, De Novo, and Q-Sub pathways.
Cybersecurity Documentation
From SBOMs to risk assessments and TPLC narratives, we support the creation and review of the artifacts regulators expect.
Gap Assessments
We evaluate your current state against evolving FDA expectations, uncovering missing elements before they become barriers.
Impact Analysis & Testing
We evaluate how discovered vulnerabilities affect your deployed systems—quantifying risk, harm, and next steps.
Mitigation & Disclosure
From regulator communication to patch planning, we help you coordinate a credible, compliant, and effective response.
Lifecycle Planning
Security doesn’t stop at launch. We help you manage ongoing risk, build cyber hygiene programs, and support internal teams.
Smarter builds.
Tighter code.
Security from the start.
Mobile Cardiac Telemetry System
Comprehensive cybersecurity consulting for mobile cardiac telemetry, throughout the full product development lifecycle.
Why We’re Different
More than a checklist. More than a scan.
Ready to Help at Any Stage
Not every project fits into a predefined path—and not every security challenge starts with compliance. We also support research teams, software developers, and security leads with targeted expertise and custom testing strategies. If it’s complex, connected, and critical, we’re ready to help.
Compliance Assessment & Submission
We review and support your regulatory submissions with precision—identifying gaps, strengthening documentation, and aligning with evolving FDA expectations.
Persistent Vulnerability Monitoring
We provide ongoing vulnerability assessment and mitigation planning to help you track, report, and respond to emerging threats in your deployed systems.
Security & Data Privacy
We help you protect sensitive health data across devices, networks, and applications—balancing usability with compliance and long-term resilience.
Software Design & Development
We support secure systems design at the source, collaborating with your team to develop custom software and tooling that’s cybersafe from day one.