EN ISO 13485 - Quality Management System for Medical Device

EN ISO 13485 - Quality Management System for Medical Device

EN ISO 13485

ISO 13485 specifies requirements for a quality management system for organizations involved in design & development, manufacturing, distribution or servicing medical devices, their parts/components or raw materials. Where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services, compliance with EN ISO 13485 is often seen as the first step in achieving compliance with European regulatory and quality management requirements.


The conformity of higher risk class Medical Devices to Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices to Regulation (EU) 2017/746 (IVDR)  must be assessed by a Notified Body before the sale European Union is permitted. The result of such a positive conformity assessment is the EU certificate of conformity allowing to affix the CE marking on the products



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