Concept Development
& Feasibility
We help define the product vision and assess technical and regulatory feasibility early in the process. Through user research, clinical insight, and proof-of-concept prototyping, we ensure the product meets real-world needs and aligns with business goals before committing to full-scale development.
Product Development
Systems Engineering
Our systems engineers lead the integration of hardware, software, and usability requirements into a cohesive architecture. We manage interfaces, define specifications, and ensure traceability from requirements through verification — enabling efficient, compliant development across disciplines.
Mechanical & Electrical Engineering
From enclosure design to PCB layout, we design and prototype hardware that meets technical, environmental, and manufacturing requirements. Our team balances performance, cost, and reliability while supporting rapid iteration and scalable production.
Embedded & Application Software Development
We develop robust, regulatory-grade software across embedded systems, mobile apps, cloud platforms, and web portals. Whether it’s firmware for a Class III device or a connected mobile app for remote monitoring, we build software that is secure, efficient, and compliant with IEC 62304 and related standards.
Industrial &
Human-Centered Design
We apply user-centered design principles to create intuitive, accessible, and safe medical products. By integrating industrial design with human factors engineering, we ensure devices are not only functional but also aligned with clinical workflows, ergonomic standards, and regulatory expectations.
Verification & Validation (V&V)
Our V&V team executes comprehensive test strategies that satisfy both quality standards and regulatory scrutiny. We conduct risk-based verification, usability testing, and validation activities to demonstrate the product is safe, effective, and ready for submission.
Manufacturing Transfer
& Sustaining Support
We guide clients through design for manufacturing (DFM), documentation transfer, and supplier coordination to ensure a smooth transition to production. Post-launch, we offer sustaining engineering support to address design updates, compliance changes, and product lifecycle management.