13485:2016
ISO 13485:2016 is a standard for the design and manufacture of medical equipment. It is an independent standard certification that is generally harmonized with ISO 9001:2015. The standard has been prepared in accordance with the European Commission with a view to the essential requirements of EU directives for medical devices and CE marking.
For ARCTIKO , the ISO 14385:2016 is a quality management system ensuring that our products meet the EU directive 93/42/EEC for medical devices.