INNOVATE
Medical device software and hardware design services
We offer the medical device design expertise and regulatory knowledge to deliver safe, effective, and compliant software, hardware, and mobile apps. We partner with our clients, from concept through finished design, to deliver develop components or complete solutions. Contact us to learn more.
INDUSTRY STANDARDS
FDA and IEC Compliance
We have developed 510K and PMA products, with safety classifications of moderate and major level of concern, to the latest IEC 60601 and ISO 14971 standards. The software and FPGA logic development and testing complies with IEC 62304, and the hardware designs complied with IEC 60601-1, including 60601-1-2 4th edition.
SOFTWARE DEVELOPMENT
Stay on track
Need help planning or executing your next project? From requirement definition through implementation and testing, we can help with expertise in these technologies:
C, C++, Java, Swift, Matlab
Embedded OS's like uC-OSII
iOS, Android, and Linux
Architecture design
State machines
Risk analysis
Requirements definition
FPGA code in VHDL and Verilog
Image processing
Simulation and verification
HARDWARE DESIGN
Deliver the goods
With 30+ years of experience, our team has the capabilities and expertise to design your product. At Innovate, hardware and software integration starts in the planning process to optimize design tradeoffs, while meeting medical industry requirements.
Our latest system design meets the 2019 IEC standards for ESD, EFT, Surge, EMC, and Isolation.
RECENT PROJECTS
FDA Approved
Upgraded legacy RF Generator with touch screen and international GUI, included hardware, software and FPGA logic.
Revised biopsy system software to implement risk mitigations.
Developed board support package firmware for RF ablation device.
Released iPhone app for low vision musician.
Created deep learning CNN for image recognition in Matlab.
CONTACT US
