ISO 13485

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. These days, many companies have to strive to maintain compliance with ISO 13485 (Medical Devices) in tandem with FDA regulations. The primary objective of ISO 13485 is to facilitate harmonized medical devices levels of quality and effectiveness. Understand how changes to ISO 13485 2003 affect the worldwide medical marketplace.