Certified for
Excellence
Our commitment to quality is backed by international certifications. Every DevaChek product meets the highest standards for accuracy, safety, and reliability.
Global Standards Compliance
ISO 15197:2015
Blood Glucose Monitoring Systems
International standard for accuracy and quality of blood glucose monitoring systems. Our DV-860 (INO) and VITA meters are fully compliant.
CE Mark
European Conformity
Conformité Européenne marking indicates compliance with EU health, safety, and environmental protection standards for medical devices.
FDA Registration
US Food & Drug Administration
Products registered with the FDA, meeting requirements for sale and distribution in the United States market.
ISO 13485
Quality Management Systems
International standard for quality management systems specific to medical device manufacturing.
ISO 15197:2015 Compliance
Our blood glucose monitoring systems meet the strict accuracy requirements of ISO 15197:2015. This international standard ensures that our meters provide reliable results that healthcare professionals and patients can trust.
Consensus Error Grid: Zero deflection recorded in both Type A and Type B blood sample testing, demonstrating exceptional accuracy.
ISO 15197:2015
Blood Glucose Monitoring Systems
Our Quality Commitment
Quality isn't just a goal—it's embedded in every step of our process, from design to delivery.
Rigorous Testing
Every batch undergoes comprehensive quality control testing before release.
Traceability
Full lot traceability from raw materials to finished products.
Controlled Manufacturing
Clean room production environment with strict process controls.
Global Compliance
Products designed to meet regulatory requirements worldwide.