Firmware & Software Engineering
IEC 62304 Design Controls & Documentation
Documentation that Drives Approvals
All software development is performed within a compliant quality framework to support FDA and EU regulatory submissions. We generate full software documentation packages including software requirements specifications, software design descriptions, verification protocols, and traceability matrices. These deliverables are ready for audit or inclusion in your design history file.
Embedded Firmware Development
Smart Firmware for Smart Devices
We design and develop firmware for a wide range of medical devices including wearable sensors, imaging systems, and electromechanical instruments. Our firmware engineers specialize in real time operating systems (RTOS), low power optimization, device drivers, communication protocols such as BLE, USB, and UART, and FPGA based control and signal processing. All development follows traceable and risk managed workflows that align with regulatory requirements.
Web &
Cloud Development
Products from the Cloud
We design and deploy HIPAA-, HiTRUST-, and GDPR-compliant cloud architectures tailored for MedTech innovation. Whether on AWS or Azure, our solutions enable seamless device data processing, analytics, and remote access. From startup to scale-up, we deliver the secure cloud foundation your medical device software demands.
Connected Devices
& Mobile Applications
Powering Smart Devices, Anywhere.
Mobile apps for iOS and Android bring medical wearables and implantables to life. We design and integrate systems connecting via Bluetooth, WiFi, or Cellular to deliver real-time data. Designed for seamless IoT integration, these solutions interface securely with EHR and LIS systems. Built to support connected care, clinical workflows, and next-generation medical device ecosystems.
Cybersecurity & SOUP Management
Securing the Stack Inside and Out
We embed security throughout the development lifecycle. This includes managing software of unknown provenance (SOUP), maintaining a complete software bill of materials (SBOM), and aligning with FDA cybersecurity expectations. We also implement secure coding practices, static analysis, and vulnerability scanning to protect your product and your users.
SaMD
Intelligence that Delivers Care
Our innovative SaMD solutions leverage mobile applications and cloud portals to enable remote monitoring, diagnostics, and personalized therapy. By turning real-time data into actionable insights, we help improve patient compliance and support more effective treatment plans. Whether it’s tracking symptoms or delivering diagnoses, our software ensures care stays connected and responsive.
Testing & Verification
Reliable Results
We implement both automated and manual test strategies to verify functionality at unit, integration, and system levels. Our team supports risk based testing, code coverage analysis, software hazard analysis, and validation activities that meet the expectations of regulatory reviewers and internal quality teams.
Machine Learning & AI
Where AI meets Compliance-Ready Design
We design and deploy AI-driven solutions that enhance device performance while aligning with evolving regulatory frameworks. From algorithm development to validation, our team ensures your innovation meets both technical and compliance standards.
We design and deploy AI-driven solutions that enhance device performance while aligning with evolving regulatory frameworks. From algorithm development to validation, our team ensures your innovation meets both technical and compliance standards.