FirsTeckBio

Italy-based IVD company. Selected diagnostic systems with local installation, training and after-sales for Italian labs, plus IVD-focused CRO and IVDR regulatory services for manufacturers.

FirsTeckBio is an Italy-based IVD company. We primarily distribute selected diagnostic systems into Italian hospitals, private laboratories and clinics — and we also offer IVD-focused CRO and IVDR regulatory services to manufacturers entering the EU.

On the distribution side, we bring selected IVD instruments and reagents — chemiluminescence immunoassay (CLIA), droplet digital PCR, immunofluorescence and POCT — into Italian laboratories with local Italian-language demo, installation, training, consumables supply and after-sales.

On the CRO and IVDR side, we design and run performance studies under Annex XIII and ISO 20916:2019, draft technical documentation, and assemble evidence packages structured for notified body review — across 20+ IVDR projects and 100+ markers, with a focus on Class D bloodborne pathogens, respiratory, women's health, cardiac and POCT.