About Us · Quality & Compliance
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.
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.