Koite Health receives ISO 13485 certification

Koite Health receives ISO 13485 certification for its antibacterial medical devices for the prevention and treatment of oral diseases and bacterial infections.


The certification acknowledges Koite Health as a designer, producer and manufacturer of medical devices. It further strengthens the role of Koite Health as a product development partner for international business in the medical device and pharmaceutical industry.


ISO 13485 is the international quality management system standard. It is an absolute requirement for the production of medical devices and equipment. The certificate ensures that all the tools, procedures, and processes of the company comply with medical services regulations, and it helps to guarantee the quality and safety of medical devices.


The ISO 13485 quality system ensures product safety and quality control through the product’s full life cycle, including subcontractor operations.


The certificate is granted by SGS, the world’s leading inspection, verification, testing and certification company.


Koite Health, established in 2018, is a medical technology company, developing disruptive antibacterial solutions to combat bacterial infections. Koite mission is to develop treatments that have a long-lasting positive impact on the well-being and health of our customers and public health. It is founded by an award-winning team of doctors and engineers and is based in Helsinki, Finland.