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

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 Inc

Ivenix Intelligent Infusion Pump

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

Mevion Medical

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.

Blogs and Resources



Meticulous Software Testing Can Save Lives

Skipping or scrimping on medical device software testing is not an option. Read more in our article in Medical Design & Outsourcing.


Checklist for Cybersecurity Documentation

The FDA now mandates elevated levels of cybersecurity compliance. Streamline the process with our handy cybersecurity documentation checklist.


Bridging the Gap Between Development & Regulatory Teams

We explore processes, tools and approaches that foster harmony among these mission-critical teams.

By partnering with ICS, you’ll benefit from accelerated time to market, decreased development inefficiencies, diminished development risk, and cost savings from enhanced usability.

Contact Us

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Mass Medic