|We provide electronic and embedded software system design and prototyping services that integrate with our customer's development processes along with design history and documentation for compliance with FDA requirements.
Our project management and development documentation expertise allows us to serve as an extension of our client's in-house team. We adapt our processes to match the specific requirements and quality standards of the project and comply with regulatory needs. This improves collaboration throughout the life of a project and captures the design history for regulatory reviews and approvals.
- CMMI-based quality practices tailored to client requirements for FDA compliance
- Project requirements gathering and analysis
- Design and test planning
- Design, test, and complete project documentation
Specific medical product realization projects include:
- Handheld diagnostic devices
- USB, Firewire, Bluetooth, and Ethernet connectivity
- 802.11x transmission system for digital x-ray images
Contact us to discuss your medical device and connectivity needs.