Innobiochips is constantly refreshing its specific know-how in order to cope with the strict regulations for IVD in Europe (IVDR).
Innobiochips has strengthened its teams with the arrival in 2024 of an additional 3-people team in charge of regulatory affairs, with highly complementary profiles:
- Romain Falcou, a specialist in CE marking for medical devices, in charge of certification according to EU standards IVDR 2017/746 and ISO 13485.
- Rayane Kameli, clinical trial & quality specialist
- Belinda Djioudji, JUNIA-HEI graduate in medical engineering
Goal: To accelerate the validation and CE IVD marking of the latest innovations developed for European markets.
Our efforts are particularly focused on the Omnys technology, which has been presented at the ISBT in Barcelona in June 2024 and Medica in November 2024.
This highly innovative technology enables multiplexed blood testing, increasing laboratory productivity by a factor of 4 and reducing waste by almost 40%