FirsTeckBio

Quality in IVD Research

Our quality approach centres on documented methods, traceable evidence and defined responsibilities. The standards and procedures for each engagement are identified in the project and study documentation.

Standards we work to

Applicable regulatory requirements and standards are identified for each device and study.

  • 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

Our Modena team works with strategically aligned organisations and the Medical Bridge collaboration network.

  • 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

Our experience includes the following study areas. The scope and resources are assessed for each product.

  • 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.

Connect with FirsTeckBio

Contact us for product, service, distribution or regulatory discussions.

Contact Us