Help:Risk Management - Accessories

G

Goutham prasad

Registered
#1
#1
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.
 
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Y

yodon

Leader
Super Moderator
#2
#2
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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