Certifications & Compliances
Commitment to Quality, Security, and Trust
At Genomize, our mission is to empower healthcare professionals and researchers with a fast, accurate, and reliable genomic data analysis platform. We believe delivering reliable results requires an unwavering commitment to the highest standards of quality, security, and regulatory compliance.
Therefore, we build trust into every layer of our software. Our certifications and compliances are a testament to our dedication to protecting your data, ensuring product excellence, and providing a service you can rely on to meet rigorous international standards.
GDPR Compliant
The General Data Protection Regulation (GDPR) is the landmark data protection law from the European Union. Genomize is fully compliant with GDPR, implementing stringent measures to uphold the privacy rights of individuals within the European Economic Area (EEA).
HIPAA Compliant
The Health Insurance Portability and Accountability Act (HIPAA) is a United States federal law that sets national standards for the security and privacy of Protected Health Information (PHI). Genomize has implemented the necessary administrative, physical, and technical safeguards to ensure the confidentiality and security of PHI.
CE-IVD Certified
The CE-IVD mark certifies that the Genomize platform complies with the European Union’s In Vitro Diagnostic Directive (IVDD 98/79/EC). This directive ensures that in vitro diagnostic medical devices meet all essential requirements for performance and safety before being placed on the market.
ISO 27001 Certified
ISO/IEC27001:2022 is the leading international standard for an Information Security Management System (ISMS). Achieving this certification proves that Genomize has established a systematic, risk-based approach to managing the security of sensitive information, including genomic and patient data.
ISO 13485 Certified
ISO13485:2016 is the internationally recognized standard for a quality management system (QMS) specific to the medical device industry. This certification validates that Genomize has implemented a comprehensive QMS that covers every aspect of our platform, from design and development to deployment and support.
Why It Matters?
These certifications are more than checkboxes. They represent our long-term commitment to building a secure, high-quality ecosystem for clinical genomics.
From the secure handling of genomic data to the reliable delivery of diagnostic results, we ensure that every stakeholder, whether in clinical labs, hospitals, or research institutions, can trust our platform with confidence.