ISO 13485 (QMS - Medical Devices Quality Management Systems)

ISO 13485 is the most accepted global standard for quality management in the medical device industry. It is issued by the International Organization for Standardization (ISO) and is considered as an ideal solution to meet the extensive requirements for a quality management system in the medical device sector.

The ISO 13485 standard characterizes discrete specifications needed for a quality management system needed by medical device organizations around the world. The certification is implemented where a corporation requires to manifest its capability to offer medical devices and related services that constantly meet customer and appropriate regulatory requirements.