Medical device software development for online automated cancer DNA biomarkers screening directly on the patients by FEW-FTIR spectroscopy

Development of FEW-FTIR (fiber optic evanescent wave Fourier transform infrared)spectroscopy as a medical device is essential for achieving the outcome of the project, so as a software development for FEW-FTIR spectroscopy as a medical device. For that, R & D is required together with certification services for its development. IEC 62304 is an international standard for the development of medical device software, whether standalone software or otherwise, in both EU and the US. Described in WO 2013/139348 skin tissue FTIR spectroscopy as a novel optical diagnostic method has a potential to work for common skin cancer detection by means of detecting in human epidermal cancerous tissue IR spectral biomarker band of the multiplet at about 1055 cm-1, correspo nding to the nucleic acids DNA and RNA molecule, determined alone and in combination with patterned appearance of DNA sequences in DNA/RNA triad over a range of frequency bands at about 1071, 1084/1085 and 1095 cm-1 related to diagnosis, prognosis and fol low-up of benign, premalignant and malignant skin tumours. For integration of this data analytical model to the product, described in the patent pending PCT/EE2013/000003 application, medical software development is required to automatically analyse patie nts data generated by FEW-FTIR spectroscopy with a view of diagnosis and monitoring of therapeutical efficacy. Here, medical device software all together refers to a program, an application and a product itself, as a standalone developed software system, i.e. not appended/integrated into a distinct product under the legal definition of a medical device (e.g. European medical devices directive MDD/93/42).