Medical Devices
& Life Sciences

Creating Transformative Products That Advance Patient Care

ICS helps medtech innovators design medical devices, in-vitro diagnostics and SaMD that enhance usability and mitigate use error. We offer deep domain expertise, specialized tools, ISO 13485-compliant processes, and a tightly coupled suite of services to accelerate development, testing and certification.

Applying IEC 62366, our software developers, HFE specialists, UX designers, and regulatory and cybersecurity experts create powerful solutions. And thanks to our experience with Agile processes, test-driven development and our own rapid-development approach, we reduce redundancies and costs, enhance software performance and compress the overall timeline of your next project.

Breas Medical Respiratory Device

Known for innovative respiratory devices, Breas Medical turned to ICS to create an intuitive user interface for its latest NIPPY device.

Ivenix Intelligent Infusion Pump

ICS helped Ivenix combine next-gen technology with simplicity in its FDA-approved intelligent fluid delivery system.

Mevion Medical Proton Radiation

Developing robust software to power the innovative Mevion S250 proton radiation therapy system, ICS helped Mevion expand access to lifesaving cancer treatment.

See Our Work

"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."

Darrin Uecker, President and CEO, Pulse Biosciences

Our Services

We're pushing the medical device industry forward with intelligent, intuitive products carefully designed to aid patients, physicians, critical-care teams and other caregivers. We offer full product realization focused around embedded, desktop and companion mobile where usability, precision and validation are safety-critical.

UX/UI & Human Factors
- IEC 62366 design
- UX strategy
- Information architecture and functional flows
- Wireframing and prototyping
- Visual and motion design
- User testing, usability, HFE research and design
Custom Software Development
- Full-stack custom software development
- GUI development and prototyping
- Application and web/cloud development
- Low-code tools that accelerate transition from prototype to product
Regulatory Services
- Software development for 510(k) and Premarket Approval (Class II and Class III)
- Software development processes compliant with ISO 13485 and IEC 62304
- Support for ISO 14971-compliant hazard analysis and dFMEA development
Cloud Connectivity
- Cloud-native development leveraging AWS, Azure and purpose-built medical cloud providers
- IoT solution design, development and analytics
- Cloud architecture and engineering
- IoT device fleet management
Software Testing
- Unit, integration and systems testing
- Development and execution of verification test plan
- Functional and non-functional testing
- Creation of verification test protocols and reports
- Tracing from design inputs to outputs to verification tests
Device Cybersecurity
- Software development to comply with FDA/EUMDR guidance
- Threat modeling
- Penetration testing
- Post-market monitoring
- Strong encryption