Examen is now ISO 13485:2016 certified

By The Examen Team

29-03-2021



BSI Assurance Mark ISO 13485:2016 certified logo

We recently passed our ISO 13485:2016 accreditation!

This seal of approval from the BSI shows our quality management system satisfies the requirements of ISO 13485:2016 and EN ISO 13485:2016 for the design, development and manufacture of in vitro diagnostic DNA-based assays for sperm cell analysis. The high quality of our Exact sperm DNA tests is evidenced in the significant number of studies we have undertaken and published in highly reputable medical journals over the past 25 years. This new certification supports the high quality sperm DNA tests and complete service that we offer.

Exact is the brand of choice amongst consultants in 80% of the UK & Ireland’s leading private fertility clinics, providing accurate assessment of sperm DNA damage, a key biomarker of male infertility. Exact tests help diagnose unexplained infertility, explain the causes of miscarriage and support experts in selecting the most effective fertility treatment for each individual patient.

We’re thrilled to have passed the accreditation which not only demonstrates the quality of the diagnostic tests we offer but reflects the expertise of the Examen team in providing the highest quality male fertility testing and results.

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