IVD-focused CRO & IVDR Regulatory Services in Italy

Start with the intended purpose and the evidence available. We support regulatory planning, study operations, medical writing and European representation, as individual services or an agreed programme.

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 and Syphilis), respiratory infectious disease, women's health, cardiac biomarkers and POCT. The public portfolio describes study types and outputs while client identities remain confidential.