Security & Compliance
Security, HIPAA & cybersecurity for connected health
Connected health products handle the most sensitive data there is. Building trust means going beyond checkbox compliance, it means designing security into the device, the software, and the operational program from day one, and protecting PHI at every layer.
Capabilities
Focus areas
HIPAA compliance & risk analysis
Medical-device cybersecurity (pre/post-market)
Threat modeling & SBOM (IEC 62304)
Encryption, access control, audit
Quality & regulatory (ISO 13485, 21 CFR 11)
Security work
Selected security & compliance work
SequenceQMS
Modern cloud-based electronic Quality Management System for medical-device companies, FDA 21 CFR Part 820 compliant, ISO 13485 ready, with AI-powered quality management.
SigmaEdge
Institutional-grade AI trading platform for decentralized markets, multi-strategy automation on AWS with sub-10ms execution.
Security Program
HIPAA & Cybersecurity Program
Security, HIPAA, and risk program for connected medical devices and health data.