UgenTec, the Belgian bioinformatics company that is developing universal & intelligent PCR analysis software, has received its ISO 13485 certification. Quickly following the new certification, UgenTec also obtained the CE-IVD label for its first product, FastFinder.
SGS and the Belgian Accreditation Organization (BELAC) granted UgenTec the ISO-certificate for "design, development, manufacturing, installation, and service of in-vitro diagnostic software for analysis and interpretation of real-time PCR data." The company also implemented the harmonized standard IEC:62304 "software for medical devices."
"Obtaining ISO 13485 & the CE-IVD label is important to our company, not only does the certificate prove our expertise & advanced quality, but also gives us a significant competitive edge in today's market," says CEO Wouter Uten.
Besides maintaining its current quality management system, UgenTec is currently in its final stages of another seed funding investment round for the PCR software's development.