Our Quality Commitment: ISO 13485:2016 Certification

Medical devices

In Koko Genetics, we believe that genetic information should be treated with the utmost scientific and health rigor. As part of the GENELINK S.L. group, we are proud to operate under an internationally certified Quality Management System.

We have obtained ISO 13485:2016 certification, the most demanding global standard for the medical device industry. This seal is not just a formality; it is the guarantee that we control the entire process:

  • We are manufacturers: We do not depend on third parties. Our parent company, GENELINK S.L., is certified for the "Design, development, and manufacture of in vitro diagnostic (IVD) medical devices, including genetic analysis software and sample collection kits".

  • Safety and Regulations: We strictly comply with medical device regulations (CE Marking) and guarantee the traceability and safety of your sample at all times.

  • Continuous Improvement: Our quality policy obliges us to constantly review our processes to offer you accurate, reliable, and useful results for your health and well-being.

When you choose Koko Genetics, you are choosing genetic analysis backed by hospital-quality medical standards.

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GENELINK SL

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