Submit with Confidence
We support device makers with targeted assessments and complete submission packages—delivering the documentation and evidence regulators expect, when they expect it.
Breadth of Regulatory Experience
From FDA to global regulators, our team has helped secure market access for a wide range of devices—hardware, software, and connected systems alike.
FDA Premarket Submissions
We support 510(k), De Novo, and PMA pathways with comprehensive cybersecurity documentation and testing evidence aligned with FDA guidance.
Global Regulatory Alignment
We help clients address international requirements, including MDR and IEC standards, ensuring submissions are compliant beyond the U.S.
Third-Party Collaborations
We work seamlessly alongside regulatory consultants, notified bodies, and internal RA teams to integrate cybersecurity into broader submission efforts.
Stronger submissions.
Faster approvals.
Regulatory clarity.
Work Products Built for Submission
We produce clear, complete, and regulator-ready deliverables designed to meet submission requirements and hold up under review.
Cybersecurity Risk Assessment
Structured assessment of system assets, vulnerabilities, and attack vectors, aligned to FDA expectations.
Cybersecurity Documentation
Full packages including risk management plans, cyber views, labeling inputs, and eSTAR-compatible files.
Gap Assessments
Detailed analysis of current documentation and security posture to identify compliance gaps.
Impact Analysis & Testing
Custom protocols and executed testing to validate security controls and support formal verification.
Mitigation & Disclosure
Collaborative support to remediate vulnerabilities and manage disclosure communications with regulators.
Lifecycle Planning
We document your software and cybersecurity lifecycle procedures to ensure they align with regulatory expectations—supporting both submission and long-term maintenance strategies.
The Harbor Labs Legacy
We don’t just test — we validate. Our methodology combines expert guidance, hands-on review, and regulator-aligned output tailored to your product.
Beyond virtual. Our secure lab facility enables hands-on testing, teardown, and verification — essential for hardware, firmware, and system-level reviews.
Persistent Vulnerability Monitoring
Continuous monitoring and analysis of known vulnerabilities (CVEs) across your deployed systems, using both SBOM and HBOM to identify and assess emerging threats postmarket.
Wearable Insulin Pump
Guiding a non-US medical device manufacturer through FDA cybersecurity gaps with analysis, revised risk assessments, testing—achieving 510(k) clearance.
Looking for something else?
We also help teams with:
Hardware Testing
Teardown and analysis of hardware systems to expose physical vulnerabilities and interface attack surfaces.
Software & Firmware Testing
Hands-on penetration testing of software components and embedded systems, based on regulatory guidance.
Security & Data Privacy
Cryptographic design, secure communications architecture, and support for regulatory-grade privacy compliance.
Software Design & Development
Custom software development and integration support across embedded systems, mobile platforms, and cloud.