The International Standards Organization 13485:2016 specification is central to ensuring medical devices achieve the quality management mandated by the governing bodies in individual countries. The driving force is to ensure predetermined accuracy and precision in a medical product. The ISO 13485 requirement is mandated by Health Canada (Class II, III, IV Medical Devices), Japan, Australia, and 28 member states of the European Union. Moreover, the FDA is moving toward modernizing and harmonizing medical device quality management systems under ISO 13485 in calendar year 2020. 

MIS has achieved ISO 13485:2016 to support the design and manufacture of medical devices as demanded by Health Canada, FDA (2020) and other governing bodies in Europe, Australia, Japan.