ISO 13485:2016 and MDSAP certificates.

ISO 13485:2016
EN ISO 13485:2016 + A11:2021
The design, manufacturing, and distribution of in vitro diagnostic reagents, test kits, and controls for use in the detection and screening of neonatal metabolic disorders. The design, manufacturing, installation, and service of microplate processing instrumentation used in the detection and screening of neonatal metabolic disorders. Contract manufacturing of reagents, test kits, and controls for in vitro diagnostic use. Contract manufacturing of 3D printed non-implantable, nonactive medical devices and medical device components for general laboratory and in vitro diagnostic use.

As a leader in the Life Sciences industry, we are committed to product quality, manufacturing effectiveness and meeting customer expectations. Copies of our certificates can be found below:

ISO 13485 certificate

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MDSAP certificate with the FDA Regulations and Canadian Medical Device Regulations

Download HERE