NEW YORK (GenomeWeb News) — Ipsogen said today it has received ISO 13485 certification covering the manufacture and sale of in vitro diagnostic medical devices at its headquarters in Marseille, France.
The certification covers Ipsogen’s blood-based IVDs for molecular analysis, diagnosis, prognosis, and follow-ups in cancer patients.
Ipsogen CEO Vincent Fert said the certification shows “compliance with a significant part of the FDA Quality System Regulation."

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