Industry Standards
& Certifications
Truth Biotechnology maintains rigorous compliance with international standards for medical device quality, manufacturing excellence, and clinical reliability.
Our Certifications
Comprehensive compliance framework ensuring product safety, efficacy, and regulatory approval worldwide.
ISO 13485
Medical Devices Quality Management
Comprehensive quality management system for medical device design, manufacturing, and service delivery.
ISO 9001
Quality Management Systems
General quality management principles applied across all manufacturing and operational processes.
CE Marking
European Conformity
In vitro diagnostic compliance for EU regulations on clinical laboratory analyzers.
NGSP / IFCC
Clinical Standards Alignment
Participation in National Glycohemoglobin Standardization Program and International Federation of Clinical Chemistry.
Quality Assurance Process
Every Truth-H60, H80, and H80E analyzer undergoes rigorous testing and validation before deployment. Our quality protocols ensure consistent performance, reliability, and regulatory compliance.
- checkComponent-level verification and source inspection
- checkFunctional testing across environmental conditions
- checkSoftware validation and cybersecurity assessment
- checkCalibration and performance benchmarking
- checkDocumentation and traceability records
Certificate Requests
Certificates of conformity, test reports, and regulatory documentation are available to qualified partners upon request through your regional distributor or our corporate headquarters.
Request Certificates