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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.