Innovative Medical Diagnostic Device Regulatory approval

A privately owned preclinical stage company has conceived a very promising innovative diagnostic method candidate, FTIR (Fourier transform infrared) spectroscopy. The preclinical proof of concept has been established by a partnering company, MC Profession al OU (Tallinn, Estonia), also privately owned at the preclinical stage. The company is looking for a Contract Research Organisation (CRO) partner to conduct the regulatory preclinical and clinical trials in order to submit an Investigational New Medical Device application in the framework of the Eurostars programme. Eurostars project objectives: Clinical research Regulatory affairs Feasibility Services As a result, cleared to sell regulatory approved novel medical device.