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Quality management system and risk management



The manufacturer shall reduce the risks to the user as far as possible without negatively affecting the benefit-risk ratio. If possible, this should be done through the use of safe design and manufacturing.

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    ​The manufacturer's work to ensure that the device complies with the regulations starts in the development phase, with the establishment of a quality management system and a system for risk management. 

    The manufacturer may use the harmonised standards for quality management system and risk management to meet the relevant requirements of the regulations.

    Quality management - relevant standard

    ​EN ISO 13485 «Medical Devices — Quality management systems — Requirements for regulatory purposes» includes among others: 

    • Management’s responsibility 
    • Resource management 
    • Development and design 
    • Purchasing 
    • Production 
    • Measurement, analysis, and improvements 

    Risk management - relevant standard

    EN ISO 14971 «Medical devices — Application of risk management to medical devices» includes among others: 

    • ​Description of the risk management process 
    • The plans for risk management, risk analysis and risk evaluation  
    • Risk reduction measures, evaluation of residual risk and benefit-risk ratio 
    • Review of the risk management activities 
    • Risk management during production and after the equipment has been made available on the market 
    • These are just two of many harmonised standards and there are several that are relevant to medical device manufacturers. See separate website for more information on Harmonised Standards​.  

    An overview of the requirements for the manufacturer's quality management system can be found in MDR Article 10 and IVDR Article 10.  ​

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