ISO 13485 - Quality Management System for Medical Device

ISO 13485 specifies requirements for a quality management system 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 requirements. 

The conformity of Medical Devices (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) 
 according to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 must be assessed before the sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according to ISO 9001 and/or EN ISO 13485 and ISO 14971 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE marking and the permission to sell the medical device in the European Union.