Regulatory Support
Navigate Compliance
with Confidence
From initial assessment through ongoing monitoring, Harbor Labs provides expert regulatory support to help medical device developers navigate complex global requirements. We don’t just help you check boxes—we help you stay ahead. Whether you’re preparing a 510(k), mapping to MDCG guidance, or responding to emerging cyber regulations, we work with your team to anticipate what’s next and ensure long-term compliance.
OUR SERVICES
Full Lifecycle Compliance for Medical Devices
We understand the unique pressures medical device teams face—because we’ve worked inside them. From prototype to postmarket, Harbor Labs offers targeted services that help you move faster, meet requirements, and maintain trust across the product lifecycle.
Compliance Assessment & Submission
Navigate FDA, EU MDR, and global requirements with confidence. We help you prepare cybersecurity documentation, risk assessments, and submission materials that meet regulatory expectations—without slowing down development.
Persistent Vulnerability Monitoring
Track, assess, and respond to emerging threats across your device ecosystem. Our monitoring approach aligns with evolving postmarket guidance and keeps you ahead of the next CVE or compliance update.
Harbor Labs was able to bring together technical know-how with a perfect-fit consultative approach to help Orpheus Medical uplift its cybersecurity code base and internal processes. [They] seamlessly worked with our engineering and product management teams.”
Tomer Ben-Sira
Orpheus Medical
Explore Additional Capabilities
We offer targeted consulting in select situations, applying our regulatory and technical expertise to help teams navigate complex challenges. Whether we’re advising on system architecture or supporting an in-house submission, our work strengthens device resilience at every layer—from firmware to connected infrastructure.
Cybersecurity Testing
Independent testing that maps real-world threats to regulatory frameworks—giving your team clear, actionable insights for remediation
Cyber Engineering
Hands-on collaboration to design, build, or strengthen secure system architectures that hold up to regulatory and adversarial pressure.