Our Methodology
We’re pioneers in the medical device space — engineers, security experts, and regulatory veterans who’ve shaped the industry. Our methodology brings you from prototype to postmarket with confidence, clarity, and zero compromise.
PROVEN PROCESS
Speed & Success
Our methodology accelerates time to market, improves submission outcomes, and builds more resilient systems. It’s not just a process—it’s a proven path forward.
01
Review
We evaluate documentation and system design, conduct stakeholder interviews, and perform reconnaissance to establish an accurate threat model baseline
02
Document
We define and refine your security posture—producing or strengthening the full set of cybersecurity artifacts needed for submission.
03
Test
We validate system defenses through rigorous penetration testing and targeted vulnerability assessments, exercising real-world threats.
04
Remediate
We develop and validate remediation plans, coordinate retesting, and confirm corrective action is complete.
05
Report
We produce a final security report—aligned with regulatory expectations and suitable for FDA or other formal submission channels
06
Repeat
Cybersecurity doesn’t end at approval. We support your product throughout its lifecycle, from postmarket surveillance to persistent vulnerability monitoring and ongoing system validation.
Give your team back hours, days, even weeks.
We’re On Your Time
Our team adapts to your roadmap—whether you’re in sprint cycles, approaching submission, or preparing a postmarket response. By anticipating hurdles and streamlining review, we help you recover your most valuable resource: time.
Wearable Insulin Pump
Guiding a non-US medical device manufacturer through FDA cybersecurity gaps with analysis, revised risk assessments, testing—achieving 510(k) clearance.
The Lab
Our in-house lab is where cyber meets hardware—purpose-built for hands-on testing, custom tooling, and real-time validation. Located near Baltimore and Washington, D.C., with easy access to Johns Hopkins, all testing is conducted onsite and domestically by our team.
Our Services
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.
At Harbor Labs, we never follow a checklist, never just run tools, never stop at the surface. If the right tool doesn’t exist, we build it. If 10 tests are adequate, we perform 20. The result is a 100% success rate with our regulatory submissions, and countless 1000s of deployed clinical systems that have gone to market through Harbor Labs.”
Nick Yuran
CEO, Harbor Labs