As part of our commitment as a regulated medical device, Quin has complied with the Medical Device Directive (MDD 93/42/EEC) for Class I devices and the following standards:

  • Application of Risk Management to Medical Devices (BS EN ISO 14971:2012)

  • Medical Device Software - Software Life-cycle Processes (BS EN 62304:2006+A1:2015)

  • Application of Usability Engineering to Medical Devices (BS EN 62366-1:2015)

  • Medical devices - Quality management systems - Requirements for regulatory purposes (BS EN 13485:2016).

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