Class II & Class III Medical Devices
We specialize in developing Class II and III medical devices that meet the most stringent global standards, including FDA and CE clearance. Our team ensures compliance with ISO 13485, IEC 60601, and ISO 14971, while addressing cybersecurity risks and human factors from the start. With deep regulatory insight and technical precision, we help you navigate complexity with confidence.
Product Development
Connected Embedded Devices
We design and develop connected embedded devices that integrate Bluetooth, WiFi, mobile apps, web portals, and cloud backends for real-time data and insights. From wearable diagnostics to remote patient monitoring solutions, our systems enable smarter, more accessible healthcare. With cybersecurity embedded at every layer, we ensure your connected devices are both innovative and secure.
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.
End-to-End Product Development
Our integrated team guides your medical product from initial concept through to commercialization, ensuring continuity and clarity every step of the way. We align design, engineering, regulatory, and manufacturing strategies to accelerate development while managing risk. With cross-functional collaboration at the core, we bring your vision to life efficiently, compliantly, and with purpose.
Firmware, Software & Cloud 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.
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.
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.
Industrial Design
& Human Factors
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.
Industrial Design
& Human Factors
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.