Technological Innovation

What is ISO-FDIS 14971:2017?

ISO-FDIS 14971:2017 is a technical standard developed by the International Organization for Standardization (ISO). It provides guidance on the application of risk management to medical devices, including in vitro diagnostic (IVD) medical devices and software used in healthcare.

Importance of ISO-FDIS 14971:2017

ISO-FDIS 14971:2017 is crucial for the medical device industry because it outlines a systematic approach to managing risks related to the safety and performance of medical devices. By complying with this standard, manufacturers can ensure that their devices are safe for patients, healthcare professionals, and the general public.

One of the key benefits of ISO-FDIS 14971:2017 is that it helps identify potential hazards associated with a medical device throughout its lifecycle – from development and manufacturing to use and disposal. This proactive identification of risks allows manufacturers to take appropriate measures to mitigate them, ensuring the overall safety and effectiveness of the device.

Key Elements of ISO-FDIS 14971:2017

ISO-FDIS 14971:2017 consists of several key elements that guide manufacturers in implementing an effective risk management system.

The first element is risk analysis, which involves identifying potential hazards and estimating their likelihood and severity. This step lays the foundation for risk evaluation, where the significance of the identified risks is assessed. Based on the evaluation, risk control measures are implemented to reduce or eliminate the risks.

Another important element is post-market surveillance. ISO-FDIS 14971:2017 requires manufacturers to monitor their devices' performance in real-world settings, collect feedback from users, and continuously assess risks. This ongoing surveillance allows for timely identification and correction of any potential issues that may arise during the device's use.


ISO-FDIS 14971:2017 plays a vital role in ensuring the safety and efficacy of medical devices. By following the guidelines outlined in this standard, manufacturers can proactively manage risks associated with their devices, minimizing the potential for harm to patients and users. Compliance with ISO-FDIS 14971:2017 is not only a regulatory requirement but also a commitment to delivering quality healthcare products that meet international standards.


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