ISO 13485 defines the requirements for a quality management system designed to demonstrate an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. (JAKARTA, INDONESIA, 17 JUNE 2016) The new edition of the ISO 13485 standard was published on March 1 2016, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new European requirements and other international regulatory changes, implemented since its previous revision in 2003. Introducing the New Revision of ISO 13485 Standard: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
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