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ISO 14971:2007, Medical devices – Application of risk management to medical devices

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ISO 14971:2007 specifies a process for a manufacturer to spot the dangers related to clinical devices, together with in vitro diagnostic (IVD) clinical devices, to estimate and assessment the associated risks, to keep watch over these risks, and to observe the effectiveness of the controls.

The necessities of ISO 14971:2007 are acceptable to all stages of the life-cycle of a clinical device.

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ISO 14971:2007, Medical devices – Application of risk management to medical devices

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