Device Risk Analysis – A Deep Look at the Purpose, Process and Application of Device Risk Analysis Using FDA-Recognized Standards
Device risk analysis is an important part of medical device development and production. It helps ensure that users can use devices safely and effectively throughout the product life cycle. It also facilitates review of new device submissions and design control documentation. In this article, we take a deeper look at the purpose, process and application of device risk analysis using FDA-recognized standards.
The first step in a device risk assessment is determining the intended use(s) of the medical device. This includes identifying the patient group the device is meant for, the medical problem it supports, and the clinical environment in which it will be used.
Next, identify all the benefits of your medical device for this patient group. This will allow you to compare them with the risks of the device and determine whether the benefits outweigh the risks.
Device Risk Analysis: Protect Against Fraud and Cyber Threats
After assessing the benefits of your medical device, it is time to start identifying hazards. This can include directly foreseeable sequences and combinations of events as well as indirectly foreseeable conditions from faults, misuse or operating in the context in which the medical device will be used.
Identify all the possible harm that could occur from each Hazardous Situation, including immediate and delayed impacts. Estimate the severity of each Hazardous Situation and the probability that it will occur.
Then calculate the residual risk for your medical device by comparing it to other devices in your market space. It is important to consider the broader market when evaluating residual risks as this will help your medical device remain competitive and profitable.