ISO 14971

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Risk Management for Medical Devices

The Risk Management Standard for Medical Devices is EN ISO 14971:2019. The Standard covers risk management throughout the life of a medical devices and for each phase of that life.

It includes the required content of the Risk Management File and in the Annexes lists likely hazards.

The standard does not provide documentation or a methodology for Risk Assessment but refers out to methodologies such as FMECA.

Atlantic Bridge can provide suitable methods to conduct Risk Management to EN ISO 14971:2019.