SolaSec partners with healthcare innovators to identify and mitigate cybersecurity risks across medical devices, embedded systems, and healthcare networks. Our specialists combine deep technical analysis with regulatory insight to help clients prepare for FDA premarket submissions, post-market surveillance, and security-focused design reviews.
Evaluates internal and external healthcare web applications, identifying vulnerabilities that could allow unauthorized access to clinical data or patient portals. Our assessments replicate real-world attacks while mapping directly to OWASP and FDA cybersecurity guidance for Software as a Medical Device (SaMD).
Analyzes iOS and Android medical applications, including patient-facing tools, clinician dashboards, and companion apps for connected devices. Evaluations include secure storage, transport-layer security, certificate pinning, and mobile-specific privacy controls.
Performs full-stack testing on connected medical products, from embedded firmware to companion software, to uncover risks across communication interfaces, hardware debug ports, and bootloaders. Our team has helped manufacturers secure Class II and III devices through threat modeling, verification of encryption implementations, and validation of security controls under FDA premarket cybersecurity guidance.
Focuses on healthcare and medical-device APIs that exchange protected health information (PHI) between applications, cloud platforms, and embedded systems. Testing includes authentication, authorization, and data integrity checks aligned with HIPAA, HL7/FHIR, and OWASP API Security Top 10.
Assesses locally installed software used in hospitals or clinical environments, such as configuration utilities and diagnostic applications. We validate encryption, privilege separation, and update mechanisms to prevent local escalation or data exfiltration in multi-user environments.
Examines the host operating systems that underpin medical devices and healthcare infrastructure. Testing includes privilege escalation, kernel-level persistence, secure boot verification, and patch validation. This service ensures compliance with FDA expectations for “known vulnerabilities” management and SBOM traceability under 21 CFR Part 820 and FDA cybersecurity draft guidance.
