ISO 13485 is an international standard that ensures that medical device organizations meet global quality management system regulations. Its aim is to provide consumers with safer medical devices and services.

Based on the eight quality management system regulations of ISO 9001 and its goal of conformity, this standard was created with the purpose of synchronizing all medical quality management systems across the globe. ISO 13485 is created for all organizations in the medical device industry (production, design, etc) and its related fields.

 …