IVD-focused CRO & IVDR Regulatory Services in Italy

FirsTeckBio is an Italy-based IVD-focused CRO. We design and run IVDR performance studies under Annex XIII and ISO 20916:2019, draft technical documentation, and assemble evidence packages structured for notified body review.

FirsTeckBio is an Italy-based IVD-focused CRO and IVDR regulatory partner. We design protocols, coordinate Italian and EU clinical sites, monitor performance studies, run biostatistics, and write the documentation a notified body will read.

The EU IVD Regulation (2017/746, IVDR) reclassified most devices into classes that require notified body review. Technical documentation must demonstrate scientific validity, analytical performance and clinical performance under Annex XIII, anchored in ISO 20916:2019 and Common Specifications 2022/1107.

Areas of focus include Class D bloodborne pathogens (HIV, HBV, HCV, Syphilis), respiratory infectious disease, women's health, cardiac and POCT — 20+ IVDR projects across 100+ markers.