Medical Devices & Life Science
Medtech Designed for Compliance, Engineered for Performance
ICS helps medical device and life science companies develop compliant new products and re-envision legacy equipment. With ISO 13485-compliant processes and deep domain experience across SaMD, in vitro diagnostics and scientific software, we support the full development lifecycle. Our multidisciplinary team applies IEC 62366 and FDA guidance to deliver reliable, submission-ready products while helping reduce costs and shorten timelines. From strategy and design to development, compliance and post-market support, our services span the entire product lifecycle.
We build medical device and SaMD software for embedded, cloud and mobile platforms with human-centered IEC 62366 UX and scalable interoperable architectures.
We deliver secure-by-design solutions aligned with FDA guidance, incorporating threat modeling, risk assessment, vulnerability management, encryption, authentication and secure updates.
We support regulatory compliance with ISO 13485 quality systems, design controls, traceability, and submission-ready documentation with FDA and EU MDR standards.
"We partnered with ICS for the software development of our CellFX® System, our first commercial product, which has received 510(k) clearance by the FDA and CE mark approval both earlier this year. As with all medical devices, design considerations are paramount to ensure functionality, safety and usability. That’s where ICS’ expertise was essential in helping us build an intuitive software-enabled, cloud-engaged device that offers discerning aesthetic skin specialists exceptional and seamless ease of use."
Success Stories
VISIE
ICS developed VISIE’s real-time 3D visualization engine, enabling high-resolution robotic surgery anatomy scans with pixel-perfect clarity across screens for precise, immersive surgical guidance.
Human Organ Transport
ICS powered an organ transport Ex Vivo Lung Perfusion system with real-time monitoring and an intuitive UI for precise tracking, secure data capture and informed clinical decisions.
