ISO 13485:2016 Medical Devices is an internationally recognized quality standard that encompasses specific requirements of an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer as well as regulatory requirements.  ISO 13485 is the most accepted standard worldwide for medical device manufacturers across the world.
The requirements of ISO 13485 are applicable to all medical device organizations regardless of size, type and structure.  ISO 13485 is beneficial for many organizations, as it is used by suppliers, as well as external parties that are involved with providing medical device products and services.
Third party review of an organization’s quality management system provides internal and external verification to customers of the monitoring, measurement and control of your processes, as well as builds confidence to meet applicable regulatory requirements. The standard is set to strive for continual process improvement and quality performance, as well as time and cost savings after implementation of this standard.