Risk Management

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The underpinning process of the entire device development is risk management. This is the cornerstone of any successful device. Your device will only be successfully launched if your risk management process has been given careful consideration. The new MDR was specifically triggered due to the poor attention manufacturers gave to risk management. Your devices risk will need to be managed “as far as possible”. Following ISO 14971 is the most suitable way to do this.

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The New MDR

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