NEW YORK (GenomeWeb News) – Eurogentec said today that its Nippon EGT business in Japan has received ISO certification for production and sale of its in vitro diagnostic oligonucleotides.
ISO 13485:2003 certification covers quality management systems relating to the design, development, production, installation, and servicing of medical devices.
Eurogentec's Nippon EGT provides its IVD oligonucleotides to molecular diagnostics manufacturers and clinical testing labs.
The certification of Nippon EGT is an "important milestone" for the company's Asia and global growth strategies, according to Peter Haimi, Eurogentec's director for diagnostic services.
Haimi said that the certification will assure Asian clients that Eurogentec "has established highly reliable, effective, and reproducible processes for manufacturing of oligonucleotides used in molecular diagnostic devices" and in lab-developed tests.
Haimi also said that the company plans to complete the same certification for its oligo production facility in North American in June.