Risk Management is a part of our daily lives. When deciding whether to take the bike, to go fast or slow we always try to choose for less risk and safety. Some of our decisions do end up not being as good we thought it would be and then we try to make better decisions. For Medical Devices risk management is a bit different than just making better decisions and moving on. It is an important task that might impact on the company if not properly mended. The responsibility of the company lies with developing a good-performing and safe product for the market. Risk Management is one of the main aspects that contributes to this, if done properly it creates so much added value to the entire operation.
ISO 14971 is the main standard for risk management in medical devices. The standard creates a framework. It does not tell you how to do the tasks, but gives you enough freedom to choose how you actually want to perform your work. Simply said, you just assess the risk, check if your estimation is correct based on the data and then update your risk management if necessary. Risk Management (RM) is an estimation at the beginning of the development since the product is not mature and you have less data about the risks. The further you get with product development, you collect more data on risk management which exceeds the estimation and RM becomes factual. Then you regularly update risk management data based on your post market activities and see if anything needs to be adjusted.
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