Bleed Monitoring System


Project: Bleed Monitoring System

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.

RBC’s speed of innovation, flexibility and dependability creates long term partnerships with our clients.
Customized Manufacturing Solutions

Our flexibility in development and manufacturing provides client focused solutions that meet their unique needs.

This client created the market for controlled tissue puncturing and required one RF Puncture Generator unit at a time. While many manufactures would be unwilling to support low volumes, we collaborated with the client to setup a responsive manufacturing scenario to scale production to the market demand.

Our willingness to solve this unique customer need has resulted in a multi-project partnership lasting over 10 years!

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510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.