ISO EN 13485:2016 is the global Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell. Notified Bodies can use this standard when assessing whether companies have a QMS, which meets European Regulation requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark. This means that companies must be conversant with ISO EN 13485:2016, the significant aspects of the regulations, relevant guidance standards and the CE mark process.
2 training days