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I have a question on a relative note. for IDE i need to submit documents of the software which controls a device. This device is used to calibrate a medical implant we are planning to get IDE. Now while writing FMEA it struck to me that the same document can be used as risk analysis. Can I do that? Can I use FMEA with a focus of patient safety and sterilization as a document which also kind of shows the risk analysis of "the calibrating device and software" combined?
Thank you,
Ravi Shah
Thank you,
Ravi Shah