Protect Your Information
We help medical device teams implement and verify security policies for embedded systems and connected infrastructure—ensuring encryption, storage, and transmission align with regulatory expectations.
Security & Data Privacy Capabilities
Identify defects before they become delays. Our testing helps medical device and software manufacturers ensure product reliability, streamline development, and meet regulatory expectations with confidence.
Secure Data Transmission
Design and verification of cryptographic modules to protect data in motion across embedded and cloud-connected systems.
Encrypted Data Storage
Implementation and validation of data-at-rest protections to safeguard sensitive information on embedded devices.
Key Management Support
Integration guidance for hardware security modules (HSMs), smart cards, and key management systems (KMS).
Regulatory-Aligned Architecture Review
Security architecture assessments to ensure systems meet FDA and IEC 81001-5-1 expectations.
Cryptographic Library
Development
Development of lightweight, certifiable libraries like MEDIC™, optimized for medical device constraints and standards.
Postmarket Monitoring Strategy
Definition of security surveillance plans aligned with Section 524B and FDA postmarket guidance.
Built-in privacy.
Stronger compliance.
Secure data.
Regulatory Compliance & Submission Support
Expert support to streamline your path to submission.
Automated External Defibrillator
Resolving an FDA hold for an AED manufacturer by fixing firmware update vulnerabilities—enabling regulatory approval, renewed sales, and improved postmarket cybersecurity.
Looking for something else?
We also help teams with:
Software Design & Development
Design, architecture, and secure implementation for embedded, mobile, and cloud platforms.
Software & Firmware Testing
End-to-end software and firmware test services including dynamic analysis and regression testing.
Vulnerability Testing
Device-focused assessments including static analysis, CVE discovery, and network protocol testing.
Persistent Vulnerability Monitoring
Ongoing risk evaluation through automated and analyst-led review of deployed firmware.