Loading. Please wait.
Our client, a spin-off from a leading US-based cardiovascular innovation center, was commercializing a 3D GPS-like surgical navigation technology that enables highly accurate minimally invasive vascular surgery with reduced radiation exposure. This is a Class III medical device.
Full Spectrum teamed with a company developing a new multi-channel infusion pump. The program was a government-funded, dual-phase engagement that begins with the development, build, and verification of a proof-of-concept (POC) prototype, with successful demonstration of POC functionality and performance to be followed by a full development and commercialization effort under design control and submitted for FDA approval.
Our client, an early-stage company, was working on a novel fluid management system to get through IDE for clinical trials. Delivery challenges with the existing vendor had already delayed clinical trials and eroded client confidence in the outcome. This is a Class III medical device.
Early-stage client developing an AED designed to be carried in a pouch for first responders and other professions that regularly interact with the public, like ushers or stadium employees. Full Spectrum was engaged to help improve requirements, create test plans/test cases, execute system and software verification, and improve the verification approach for the proprietary ECG analysis algorithm for this Class III medical device.