WE ARE INTERNATIONALLY CERTIFIED
Quality and reliability in manufacturing medical devices
ISO 13485 is a standard for the design and manufacture of medical equipment. It is an independent standard certification that is generally harmonized with ISO 9001. 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 13485 is a quality management system ensuring that our products meet the EU directive 93/42/EEC for medical devices.
ISO 9001 is the most widely used International standard in the world. It streamlines and documents Arctiko’s working processes and ensures that production always meets the high quality expectations of Arctiko’s partners.
MEDICAL DEVICE DIRECTIVE
EU directive 93/42/EEC for medical devices & CE marking for Class II equipment.
Arctiko is registered and has listed the following medical device with the U.S. Food and Drug Administration for FY 2016 Pursuant to Title 21, 807 et seq. of the United States Code of Federal Regulations.
Arctiko products are approved according to following standard(s): UL 471 issued: 2010/11/24 Ed.: 10 Rev: 2014/11/17 Commercial Refrigerators and Freezers.
CSA C22.2#120 Issued: 2013/03/01 Ed: 4 Refrigeration Equipment