Gradientech achieves transition accreditation toISO 13485:2016
“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.