ISO 13485 is a standard that represents the requirements of a comprehensive quality management system for the design and development, production, storage, distribution, installation and servicing of medical devices. It specifies requirements for organizations involved in one or more stages of the medical device life cycle.
ISO 13485 can also be used by importers or the appointed agency who import and distribute medical devices who maybe mandatory to set up medical devices quality management system as to comply with their local regulation
Those companies who are certified to ISO 13485 are explicitly expect to comply with all the applicable regulatory requirements and established a risk based approach risk managements quality management system for its processes including the outsourced activities.
ISO 13485 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, storage, distribution of medical devices activities and other aspects of the quality management system.