What is ISO-FDIS 14971:2017?

ISO-FDIS 14971:2017 is an international standard that provides guidelines for the application of risk management to medical devices. This standard aims to help manufacturers and healthcare professionals identify and assess potential risks associated with medical devices, as well as implement effective control measures to mitigate these risks.

Understanding the Importance of ISO-FDIS 14971:2017

In the medical field, patient safety is of utmost importance. ISO-FDIS 14971:2017 plays a crucial role in ensuring the safety and effectiveness of medical devices throughout their lifecycle. By adhering to this standard, manufacturers can evaluate the risks associated with their products, from design and development to manufacturing, deployment, and post-market surveillance. It helps them identify potential hazards, estimate their probability of occurrence, and determine the severity of harm that may result from these hazards.

Key Principles of ISO-FDIS 14971:2017

ISO-FDIS 14971:2017 follows a systematic approach to risk management. The key principles outlined in this standard include risk analysis, risk evaluation, risk control, and risk management review. Let's take a closer look at each principle:

Risk Analysis: This involves identifying and assessing risks associated with the medical device. Manufacturers need to consider various factors such as device characteristics, intended use, potential users, and potential hazards.

Risk Evaluation: Once the risks have been identified, they are evaluated based on the criteria specified by the manufacturer or regulatory authorities. This helps prioritize risks and decide on the necessary actions to control or eliminate them.

Risk Control: This stage focuses on implementing appropriate measures to reduce or eliminate risks. It involves establishing risk acceptance criteria, implementing risk control measures, and verifying their effectiveness.

Risk Management Review: Regular review of the risk management process is essential to ensure its ongoing effectiveness. This includes monitoring the performance of the medical device, feedback analysis, and making necessary updates to the risk management plan.

Conclusion

ISO-FDIS 14971:2017 plays a critical role in ensuring the safety and reliability of medical devices. By adhering to this standard, manufacturers can identify potential risks associated with their products and implement effective control measures to mitigate these risks. The systematic approach provided by ISO-FDIS 14971:2017 helps ensure that all aspects of risk management are addressed throughout the lifecycle of the medical device, ultimately leading to improved patient safety.