Risk management, from my understanding, is the act of ensuring your device is free from unacceptable harm. I believe the first step in any risk management plan is to determine your potential sources of harm that are directly related to the medical device. For example if you have a medical device that emits an electrical output, one hazard to the patient can be electrical shock. The first step in an effective risk management plan is to determine these types of hazards and then the next step would be to manage/mitigate the potential situations that would expose us to that harm. That would be done by first assessing the level risk associated with the hazard and then implementing effective measures against those hazards that have been deemed to have too high of a risk. Such mitigation steps could include encasing the battery which provides voltage to prevent exposure to the patient or by using strong adhesive to ensure the patient cannot have access to the internal circuit board that controls the device.
Through my work experience, I have worked with two different methods such as FMEA’s and biocompatibility test. Most recently more so with FMEA with suppliers that provides critical finished devices to us for a top level kit. This was not the only means for risk management performed, just the only portion in which I was involved. FMEAs are comprehensive approaches to determining multiple avenues of failure associated with a medical device then assigning severity, detection, and occurrence values to form an RPN value. Additionally controls are introduced with the FMEA to help mitigate those potential causes of failure and additional controls can be implemented as additional mitigation measures if need be dependent on the calculated RPN value.