Embedded Firmware Development
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.
Firmware & Software Engineering
Application Software Development
Our team builds modern, intuitive applications for mobile, desktop, and web platforms, including clinician dashboards and patient facing apps. We prioritize usability, responsiveness, and data security while ensuring applications comply with standards such as IEC 62304, HIPAA, and FDA SaMD guidance.
Software Architecture & Design
We architect scalable and maintainable software systems that support clinical reliability and long term product evolution. Our approach includes modular design, interface definition, hardware abstraction layers, and documentation aligned with your quality system. We focus on building software that is both feature ready and future ready with compliance built into the foundation.
Cloud Development
We design and build secure and scalable cloud systems that support medical data storage, analytics, remote access, and device connectivity. Our platforms are architected to support HIPAA compliance and integrate seamlessly with mobile apps and embedded systems. Whether hosting a SaMD platform or managing device fleets, we provide cloud solutions with secure APIs, role based access, audit logging, and operational reliability.
Design Controls & Documentation
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.
Testing & Verification
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.
Cybersecurity & SOUP Management
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 and IMDRF cybersecurity expectations. We also implement secure coding practices, static analysis, and vulnerability scanning to protect your product and your users.