ISO 14971 is a standard that provides the requirements for a risk management system for medical devices. The latest revision of ISO 14971 was published in 2009.

This standard establishes the requirements for manufacturers to perform risk management to determine the safety of their medical devices. It is a necessary part of any medical device’s R&D process and the implementation of a medical device quality management systems such ISO 13485 and 21 CFR 820. The Risk Management document should identify the risks associated with the device’s function, its intended use and indications and provide a mitigation plan to address those risks.

Contact us for any assistance you may need in preparation or implementation of your device’s risk management report. Training, step by step guidance, onsite or online consulting are available to help you comply with ISO 14971.

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