Compliance & Certifications
Golden Helix is dedicated to maintaining the highest standards of quality and regulatory compliance, ensuring our clinical genomic analysis solutions meet the rigorous requirements of diagnostic laboratories worldwide.
CE-IVD
VarSeq Dx is a in vitro diagnostic medical device CE-marked under Regulation (EU) 2017/746 (IVDR).
It is intended for use in clinical genomic analysis within diagnostic laboratory workflows in the European Economic Area (EEA), providing clinicians with a robust and compliant platform for patient care.
ISO 13485:2016
As part of our compliance with the IVDR, Golden Helix operates under a Quality Management System certified to EN ISO 13485:2016.
Our QMS is focused on maintaining exceptional quality, demonstrating comprehensive risk management, and conducting continual post-market surveillance to monitor customer satisfaction and safety, while driving the ongoing improvement of our products.
TÜV SÜD
Certification Body
Standard
ISO 13485:2016
Certificate No.
Q5 115569 0001 Rev. 00
GDPR
The General Data Protection Regulation (GDPR) establishes strict requirements for the protection of personal data of individuals in the European Union and European Economic Area.
Golden Helix is committed to supporting customers in meeting their GDPR obligations. VarSeq includes technical and security controls designed to facilitate lawful processing, access management, auditability, and protection of personal data when implemented within a compliant organizational framework.
Committed to Excellence
Our certifications are more than just badges—they represent our ongoing commitment to the quality, safety, and security of your genomic data.