We are now ISO 13485:2016 certified – the international gold standard for medical device quality management systems.
In medical diagnostics, this is not a nice-to-have. It is a prerequisite.
This certification confirms that our technologies are developed, maintained, and delivered according to the highest quality and regulatory standards required in the medical device industry.
It also marks a structuring step in the journey of #MSIcare, our genomic data analysis solution dedicated to the detection of tumor biomarkers in oncology – as we progress toward CE-IVD marking.
What this means concretely:
✅ A quality management system fully aligned with medical device regulatory requirements
✅ Audited and certified by GMED, our notified body
✅ A foundation for CE-IVDR certification
✅ A signal to our partners that MSInsight operates at medical-grade standards
Our conviction remains unchanged: Transform the complexity of genomic data into clinically actionable information for oncologists — so that every patient can access the right treatment.
Congratulations to the entire MSInsight team for this execution. Special recognition to our QARA team for driving this achievement with rigor and determination.
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