Help:Risk Management - Accessories

Goutham prasad

Should we have to take the accessories into account while undertaking risk management for the medical device? Additionally, the risk assessment for the breathing circuit should be performed (for example, a medical cpap device). Additionally, how should the strategy be for accessories if we manufacture them with the device and how should it be if we purchase third-party accessories if we are purchasing the circuit from a third-party vendor, testing it, and selling it to the client.


Super Moderator
Yes! They perform some function so what if that function fails? With a 3rd party, you always have the risk (so to speak) of uncontrolled changes (especially materials ... and especially if contacting!).
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