QuickMIC Instrument Certified for Research Use
“The certification proves our QuickMIC instrument to be safe for use according to regulatory requirements. This is a receipt for Gradientech that we have been successful in our development work so far and that our focus on quality has paid off,” says Sara Thorslund, CEO at Gradientech.
The QuickMIC system for ultra-rapid antibiotic susceptibility testing can be used for diagnostic purposes once the current certification is complemented with proven clinical performance according to regulatory requirements. The clinical performance study of the QuickMIC system, in collaboration with European clinical microbiology labs, is planned for 2021. Gradientech is ISO13485 certified since 2017, which is a requirement for placing a medical device product for diagnostic use on the market.