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Quality management system standard EN ISO 13485:2016
EN ISO 13485:2016 is a standard that supports medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes.
The standard puts an emphasis on regulatory requirements, custom requirements, risk management and maintaining effective processes such as safe design, manufacture and distribution of medical devices.
The certificate is published by the International Organization for Standardization (ISO) titled “Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes”.
Declaration of conformity
(according to EN ISO 13485:2016)
