Take a look at some of our past client projects, from patient monitors to implanted devices, IVD companion diagnostics, and laboratory instruments. We look forward to the opportunity to help you successfully commericalize your medical device innovations!
Clinical Alarm Management
Design, implement, and test software on a legacy defibrillator-monitor product to address IEC-60601-1 requirements, including Alarm Management and other BASIC SAFETY...
System Performance Optimization
Study the performance bottlenecks in product that contribute to hazardous situations. Provide recommendations to architecture changes and implementation to improve performance and recover system resources to enable the...
Legacy Software IEC-62304 DHF Audit
Create IEC-62304 life cycle documentation for a legacy product, including the software architecture specification aligned with upper level requirements specifications. Assign the safety classification for the individual software items based on the...
CDx Software Analysis & Automation
Perform a cross-functional system analysis to study the feasibility of automating the development process of in vitro companion diagnostic devices for multiple drug ...
PCR Data Analysis & Reporting
Develop an integrated development environment for developing Companion Diagnostics applications, using a common workflow that guides the user through performance and functional synthesis, with built-in consistency...
System Reliability Analysis
Conduct a comprehensive system reliability and failure analysis on the instrument, and propose an Error Handling architecture that effectively mitigates the hazardous situations and improves the overall instrument service performance.
Low Power, Secure Bluetooth Communications
Development of secure data communications over a Bluetooth (BLE) link connecting legacy insulin pump (pod) with a 3rd party user interface device and a system controller module. Support validation of hardware architecture (processor module, BLE transceiver), signal quality assessment, system integration and testing...
Ventricular Assist Device Real-time Control Software
Develop a data logging service for an embedded software system comprised of multiple inter-connected microprocessors, and provide a means to connect real-time monitors to view streaming data using a USB interface.
Hemodialysis 510(k) Submission
Systems engineering activities including leading risk management activities, creating system specifications aligned with system requirements and user needs, sub-systems specifications aligned with design inputs and architecture, and completion of Risk Management files.
Contact us today to find out how we can help with your product development needs.