The ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations. ISO 17664 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilisation to ensure that the device is safe and effective for its intended use. ISO 10993 Biological evaluation of medical devices, Evaluation and Testing within a Risk Management Process, is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. GMP Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Also cGMP from FDA USA , GMP Pharmaceuticals, Goods Distribution Practices for Medical Devices ( GDPMD) , Good Storage Practices ( GSP) ,