Arctiko is internationally certified

Quality and reliability in manufacturing medical devices

Arctiko is certified after the International Standard ISO 9001-Quality Management and ISO 13485-Quality Management for Medical Devices

ISO 9001 shows our ability to consistently provide products that meets our customers and applicable regulatory requirements. We aim to enhance customer satisfaction through the effective application of our system, including processes for continual improvement of our products.

ISO 13485 is a comprehensive management system for the design and manufacture of medical devices. This certificate demonstrates our ability to provide, not only medical devices, but also medical services to constantly meet our customer’s requirements.

FDA Certified

ARCTIKO is certified and registered with FDA
View certificate of registration »