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Zentech
Certifications
Certifications are more than a legal obligation; they are also an opportunity for ZenTech to continuously advance and sustain its business. Therefore, in addition to being ISO 13485:2016 certified, standards that specify the requirements of the Quality Management System (QMS) for the medical device industry, ZenTech is also ISO 9001:2015 certified, which specifies the requirements of quality management systems in general.
On April 5, 2017, the European Commission approved the new European Union In Vitro Diagnostic Medical Devices Regulation. ZenTech is prepared for the newest European (EU) 2017/746 regulation on in vitro diagnostic medical devices to be applied from May 2022.