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BS EN ISO 14971 / BS EN 62366 - Medical Devices Package

     

Application of Engineering and Risk Management to Medical Devices: BS EN ISO 14971 and BS EN 62366 (British Standard)

The BS EN ISO 14971 / BS EN 62366 - Medical Devices Package specifies usability engineering and risk management processes intended to minimize use-associated errors and risks. It also provides the means to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls for medical devices. BS EN ISO 14971 / BS EN 62366 - Medical Devices Package includes:

  • BS EN ISO 14971:2012
  • BS EN 62366:2008+A1:2015

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