Risk Management for Medical Devices According to ISO 14971

Risk management is a fundamental process in the lifecycle of a medical device, aimed at ensuring the safety and efficacy of the device for patients and users. According to ISO 14971, the international standard for risk management of medical devices, manufacturers are required to establish, document, and maintain a risk management process throughout the entire lifecycle of the device.

The main challenges in this process include identifying potential hazards, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls implemented.

Proper risk management is crucial to prevent harm to patients and users, ensure regulatory compliance, and maintain market access.

Our medical device team offers comprehensive risk management services tailored to the unique needs of your device. 

We handle risk management in multiple ways

What can we do for you?

Our medical device team can engage with you at any stage of the device lifecycle, from initial development to post-market surveillance. Whether you are developing a new device or managing an existing one, we are here to ensure your risk management process is robust, compliant, and effective.

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Metehan Agaca
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Metehan Agaca
Senior RA Manager

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