Risk analysis is a vital part of the medical device development process. It identifies potential hazards and hazardous situations, estimates risks and allows the device manufacturer to develop and implement smart strategies to mitigate them. This will keep patients safe, and help manufacturers maintain their compliance with regulatory requirements.
There are a few different methods for performing a device risk assessment, depending on the complexity of your product and the availability of resources. Many of the more sophisticated options rely on fault trees or other sophisticated modelling tools. However, for an initial risk assessment before you have a finished or prototype device to look at, a less structured approach might work best. For example, you can create an overview block diagram or simply write down a description of your device.
How Device Risk Analysis Helps Prevent Fraud
The first step in device risk analysis is to identify your intended use of the product and any reasonably foreseeable misuses. This is important because the team designing the device may have unique knowledge of the product that could lead to unforeseen use errors. Formative testing will help identify these unforeseen hazards.
Once you have a clear understanding of the intended and foreseeable misuses of your medical device, it’s time to start identifying and evaluating hazards. This involves working with clinical subject matter experts to think about the possible outcomes of each use error, assessing the severity of these consequences and how they can be avoided or mitigated.
Once all the risks have been identified and evaluated, you can then consider implementing risk control measures to reduce these hazards and prevent harm. This can include tweaking the design, modifying the manufacturing process or creating clear warnings and instructions on how to safely use your medical device.…