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News 2017-11-23

Gradientech receives ISO 13485 certification

Gradientech AB has received ISO 13485 certification, an important milestone and a regulatory requirement towards the goal of CE-marking our in vitro diagnostic system QuickMIC™ for ultra-rapid antibiotic susceptibility testing (AST).

ISO 13485 is the world’s most widely used standard for quality management system requirements for medical devices.

The ISO certification demonstrates that Gradientech has implemented a quality management system that ensures high quality and consistent design, development, manufacturing, support and sale of microfluidics based products for the determination of cell responses to concentration gradients and that are safe for their intended purpose.

Link to press-release

Gradientech is an ISO13485 certified company since 2017


Gradientech AB
Uppsala Science Park
SE-751 83 Uppsala

About Gradientech

Gradientech develops, manufactures and sells innovative microfluidic products for high-quality analysis of the behavior of cells and organisms in response to gradients of biomolecules. Our aim is to pioneer life science and healthcare.

Copyright © 2023 Gradientech. All rights reserved. Gradientech, QuickMIC and CellDirector are registered trademarks or trademarks of Gradientech AB.

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