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Quality guaranteed

All ChromoQuant products are CE/IVD labelled medical devices, produced by CyberGene. CyberGene hold an ISO Certificate for ISO13485-2016. IVD products and services are developed, produced and brought to market under strict quality control.

Download copy of valid ISO13485-2016



CyberGene´s quality policy

When developing, manufacturing and selling CE/IVD products for human genetic testing:

CyberGene´s primary goal is to obtain full customer satisfaction and to fulfil relevant regulatory requirements.

CyberGene´s customers shall always be guaranteed full traceability of the products.

CyberGene shall fulfil the needs and expectations of our customers by relying upon a sustainable and continuously reviewed and improved Quality Management System.

CyberGene´s qualified and knowledgeable personnel shall support our aims for producing high quality products and for rapid support to customers.

Each individual within CyberGene shall be responsible for executing their work in a professional and prudent manner, in accordance with established procedures.











CyberGene AB, Banvaktsvägen 22, 171 48 Solna, Sweden. 
CyberGene® and ChromoQuant® are registered trademarks of CyberGene AB

Since June 2021, CyberGene is a subsiduary of AlphaHelix Molecular Diagnostics AB