Harbor Labs

Harbor Labs is a specialized cybersecurity and regulatory consulting firm focused exclusively on connected medical devices and healthcare software systems. The Baltimore-based team comprises computer scientists and system security engineers who work with medical device manufacturers throughout the product lifecycle—from initial architecture design through FDA submission and post-market surveillance.

The firm provides three core service areas: cybersecurity testing (including penetration testing, vulnerability assessments, and hardware analysis), regulatory support (eSTAR documentation, 510(k)/PMA submissions, IEC 62304 compliance), and cyber engineering (secure firmware development, encryption implementation, and security architecture design). Their client portfolio includes major medical device manufacturers like Baxter, Dexcom, and Intuitive, as well as government agencies including HHS and the Department of Justice.

Harbor Labs differentiates itself through deep technical expertise in medical device security combined with regulatory fluency in FDA requirements. The firm has worked across diverse device categories including surgical robotics, cardiac telemetry systems, infusion pumps, wearable monitors, and genomic sequencing equipment.

Choose Harbor Labs when you need deep technical expertise in medical device security combined with regulatory fluency for FDA submissions. The firm excels in complex, multi-component medical systems where cybersecurity intersects with patient safety—particularly for devices requiring FDA clearance or addressing critical vulnerabilities in deployed products.

Expect a collaborative, technically rigorous engagement where Harbor Labs engineers work alongside your development and regulatory teams. Their approach emphasizes building security into product architecture from the beginning rather than treating compliance as a final checkpoint before submission.

Harbor Labs operates exclusively in the medical device and healthcare software security domain. Their entire service model is built around FDA regulatory pathways (510(k), PMA, Q-Sub) and medical device standards including IEC 62304, IEC 62443, and AAMI TIR57. The firm demonstrates specialized expertise across multiple healthcare device categories including cardiac monitoring systems, surgical robotics, infusion pumps, dialysis equipment, wearable health monitors, and genomic sequencing platforms.

Their approach integrates patient safety considerations with cybersecurity threat modeling, reflecting deep understanding of how vulnerabilities in medical systems translate to clinical risk. Case studies demonstrate experience with multi-patient harm analysis and clinical workflow considerations specific to healthcare delivery environments.

Medical device manufacturers developing connected Class II or III devices, particularly those with embedded firmware, wireless connectivity, or cloud infrastructure components. Organizations facing FDA cybersecurity questions during premarket review, companies remediating vulnerabilities in marketed devices, and development teams building next-generation surgical, diagnostic, or monitoring equipment where security architecture must be designed from inception.