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BS EN ISO 14971 / BS EN 62366 – Medical Devices Package
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 14971:2019+A11:2021
BS EN 62366-1:2015+A1:2020
BS EN ISO 14971 / BS EN 62366 – Medical Devices Package includes:
BS EN 62366-1:2015+A1:2020
BS EN ISO 14971:2019+A11:2021
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