How to Do an Effective Online Device Risk Analysis
When developing a medical device you will be required to carry out a risk analysis. This is one of the foundations of your design validation process and a key component to getting your product on the market. But a lot of people struggle with how to do this effectively and efficiently.
The current “state of the art” in risk management can be found in the ISO 14971 standard (formerly EN ISO 14971:2007). This is particularly helpful as it lays out the requirements, expectations, and stages of a good risk management process. This standard is also required by the EU MDR if you are selling your medical device in Europe.
Before you can do any online device risk analysis, you need to understand your product and how it will be used. To do this you need a Hazard and Risk Matrix that is specific to your device. This should include the Severity, Probability of Occurrence, and a description for each of the Hazardous Situations.
Online Device Risk Analysis: Identifying Fraudulent Activities
Throughout the development of your medical device, you will need to continually revisit this matrix and ensure that all risks are being adequately mitigated. This could be by using different mitigation strategies such as comparing your product to similar or competing products, having application specialists or experts review your risk control measures, or a combination of these.
Once your risk analysis is complete you will need to compile a risk management report. This can be as simple as meeting minutes or it can be more complex with flow charts describing your thought process. You will also need to maintain records of all of the persons that performed the analysis. This is another requirement from the ISO 14971 standard as auditors will often request to see proof that risk management tasks were completed by a person with education, training, and skills appropriate to the task.…