Abstract

This guide is intended to help organizations in the medical devices sector implement the requirements of International Standard ISO 13485, thereby demonstrating their ability to provide products and related services in compliance with the laws and regulations of the medical devices industry. Such organizations, which may be involved in one or more stages of the life cycle or supply chain of a medical device, include manufacturers, importers, distributors, service providers or authorized representatives. In addition, this handbook can be useful to regulatory authorities and certification bodies concerned with conformity to ISO 13485.