Development and submission to the FDA of the technical file of the Electrical Impedance Tomography ENLIGHT 1800

• Grant number: 13/50774-2
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: July 01, 2015
• End date: November 30, 2016
• Field of knowledge: Engineering - Biomedical Engineering
• Agreement: FINEP - PIPE/PAPPE Grant
• Principal Investigator: Igor Nowaski Candiani
• Grantee: Igor Nowaski Candiani
• Company: Timpel S/A
• City: São Paulo

Abstract

The proposed project aims to develop the technical file of THE Electrical Impedance Tomography model ENLIGHT 1800 and submit it to the FDA (United States). In September/2013 Timpel began the process of European certification of the same product, and it has already developed the technical file required by European authorities. However, the FDA stricter requirements such as the documentation (especially on software), verification and validation, which should be done in the United States. No other similar Electrical Impedance Tomography was approved by the FDA, and not many Brazilian medical devices have been certified by FDA. The project is crucial for the commercial success of Timpel, given the fact that the United States represents approximately 40% of the world market, and is a market required for Timpel to achieve breakeven in 2016. (AU)