Sekurno is a cybersecurity services firm specializing in penetration testing for software-based medical devices, with a focus on FDA regulatory alignment. The company targets medical device manufacturers who need to demonstrate cybersecurity assurance as part of premarket submissions to the U.S. Food and Drug Administration. Core service offering: - FDA-aligned penetration testing for Software as a Medical Device (SaMD) and connected medical technologies - Threat modeling and cybersecurity risk assessments mapped to FDA Premarket Cybersecurity Guidance - Manual penetration testing, secure code and logic review, and automated vulnerability scanning (SAST/DAST) - Third-party and supply chain component risk analysis, including SBOM support - Post-market vulnerability management support Testing scope covers application interfaces, mobile apps (Android/iOS), APIs, cloud and platform services, connectivity interfaces (Bluetooth, Wi-Fi, USB), and embedded/third-party software components. Sekurno follows recognized methodologies including PTES (Penetration Testing Execution Standard), OWASP Application Security Verification Standard, OWASP Web Security Testing Guide, and OWASP Mobile Security Testing Guide. Deliverables include penetration testing reports, threat model documents, test coverage checklists, and letters of attestation — all structured to support FDA submissions. Beyond FDA, the company also provides compliance-oriented testing aligned with HIPAA, EU MDR/IVDR, ISO/IEC 27001, and SOC 2 frameworks. Their services are positioned for medical device manufacturers preparing for regulatory submissions, certification audits, or client due diligence reviews.