FirsTeckBio

Standards, track record and domain depth.

Three things define quality for an IVD partner: the standards the work is built on, the projects already delivered, and the depth in a defined clinical area. FirsTeckBio commits to publishing all three rather than claiming generic ISO compliance.

Standards we work to

Every regulatory and CRO engagement is structured around explicit, public standards — not internal opinion.

  • IVDR 2017/746: EU In-Vitro Diagnostic Regulation — the legal frame for every project we run inside the EU.
  • ISO 20916:2019: Clinical performance studies for IVD devices — design, conduct and reporting.
  • ISO 13485 · ISO 14971 · IEC 62366: QMS, risk management and usability engineering anchors for technical documentation.
  • Common Specifications 2022/1107: Mandatory Common Specifications for Class D devices (HIV, HBV, HCV and other listed analytes).
  • CLSI guidelines: EP05 (precision), EP09 (method comparison), EP17 (limits of detection), EP35 (matrix equivalence) — applied across analytical performance studies.

Operating reach

Current figures are stated with their boundaries so alliance scale is not confused with direct headcount or owned clinical infrastructure.

  • 2021: FirsTeckBio founded in Modena, Italy.
  • IVD: Specialist domain across product, regulatory, clinical and data workflows.
  • 90+: Combined alliance team across three strategically aligned Italian organisations.
  • 200+: Medical Bridge collaboration network, not FirsTeckBio-owned sites.

Domain depth

We commit to areas where we have repeat experience, rather than claiming all-IVD coverage.

  • Class D bloodborne pathogens: HIV, HBV, HCV, Syphilis — performance studies, validation against EU reference panels, technical documentation under Common Specifications 2022/1107.
  • Respiratory infectious disease: Influenza, RSV, SARS-CoV-2 and multi-pathogen panels.
  • Women's health & male reproductive: HPV, hormonal markers, sperm DNA fragmentation.
  • Cardiac & inflammation markers: Troponin, BNP/NT-proBNP, CRP, PCT, D-dimer.
  • POCT & self-tests: Lay-user and near-patient devices with IEC 62366 usability requirements.

Ethics & data protection

Integrity and data-handling standards applied across distribution and regulatory engagements.

  • Business ethics: Integrity and transparency in every commercial and regulatory relationship.
  • Anti-corruption: Zero tolerance for bribery and corruption in tender and procurement engagements.
  • Data protection (GDPR): EU Regulation 2016/679 (GDPR) for personal data; IVDR rules for clinical-study and patient data.

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