Gradientech achieves transition accreditation toISO 13485:2016
Uppsala, February 15, 2019. Gradientech AB has successfully transitioned to the latest revision of ISO13485:2016,an important regulatory requirement forCE-marking of our in vitrodiagnostic system QuickMIC™for ultra-rapid antibiotic susceptibility testing (AST). “We are very pleased to have obtained this certification, since it accredits that our company has the ability to provide medical devices that meet customer and internationalregulatoryrequirements”, said Sara Thorslund, co-founder and CEO of Gradientech.
“We are very pleased to have obtained this certification, since it accredits that our company has the ability to provide medical devices that meet customer and internationalregulatoryrequirements”, said Sara Thorslund, co-founder and CEO of Gradientech.
ISO13485 is the world’smost widely usedinternational standard forquality management system for medical devices. The 2016 version of the international standard is a major revision of the 2003 version, with a heavy focus on risk management and risk-based decision-making processes at both the quality management system and product levels.Thiscertificationdemonstratesthat Gradientech has aquality management system that ensures high-quality andconsistent design, development, manufacturing, sales and support formicrofluidic-based products for the determination of cell responses to concentration gradients.
For further information, please contact:
Sara Thorslund, PhD, CEO Gradientech
Tel: +46 736 29 35 80
sara.thorslund@gradientech.se
About Gradientech
Gradientech is a diagnostics company developing the in vitro diagnostic QuickMIC® system, a new platform for antibiotic susceptibility testing based on phenotypic bacterial growth analysis. The system is expected to become the most rapid solution for determining appropriate antibiotic treatment of sepsis patients. Rapid antibiotic susceptibility testing is vital for increasing sepsis patient survival, reducing healthcare costs and lowering the spread of antibiotic resistance. www.gradientech.se
