Client Need:
- Commercialize a first to market technology to detect bleed occurrence associated with endovascular procedures
- Embedded electronics and software
- Proprietary algorithm implementation
- Design verification and software validation
How RBC Added Value:
RBC provided design and development efforts for feasibility of the initial device. We developed the embedded electronics and software for the user interface device which included implementing the client’s proprietary and complex algorithm for bleed detection. Our team also developed a simulated bench top bath model which was used for verification and validation requirements. We continued to support the project through certification and de novo regulatory approval. This project demonstrated our knowledge and experience in electromechanical medical device design and development coupled with the ability to solve complex engineering problems associated with unique applications.
The client was satisfied through the complex design and testing of the device and returned to RBC for subsequent feature enhancement programs to refine performance and improve user experience. RBC supported this update through completion of testing requirements for FDA and CE mark submission and FDA technical file updates.
