HomeNewsISO 13485 Certification for MetaSystems Group USA
ISO 13485 Certification for MetaSystems Group USA
Feb 6, 2017
Our US team was recently awarded ISO 13485 certification! Here are some pictures taken during the celebration. At MetaSystems, we strive after continuously improving the quality of our service and products!
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2016, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
You can find the certificate here. The effective date is November 2nd 2016.
MetaSystems products are used in many countries worldwide. Depending on the regulations of the respective country or region, some products may not be used for clinical diagnostic use. In Europe MetaSystems products are CE labelled in-vitro diagnostics (IVD) devices. In the USA all MetaSystems products except the Ikaros karyotyping systems are intended to be used for research or inspection only.
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