FirsTeckBio

Italy-based IVD company selling selected diagnostic systems with local support, plus IVD-focused CRO, IVDR services and RT Clinica EDC for manufacturers.

FirsTeckBio is an Italy-based IVD company. We distribute selected diagnostic systems into Italian hospitals, private laboratories and clinics, provide IVD-focused CRO and IVDR services, and offer RT Clinica EDC for performance-study data.

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.

For manufacturers, 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. RT Clinica adds versioned eCRFs, review, signatures, lock and traceable exports as a dedicated software product or separately scoped CRO data layer.