One of our devices requires servicing

#1
Hi everyone,

One of our devices requires servicing. However, in the case that a customer forgoes a servicing contract, is the manufacturer responsible for training them on routine maintenance? If the user is trained in routine maintenance, if they discover an issue affecting safety/performance of the device, what is the manufacturer's responsibility toward that customer? In other words, can the manufacturer contract away their servicing obligation under 13485?

Thank you.
 
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Ronen E

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#3
Servicing obligation?
It’s all up to the manufacturer to define.
Once definitions are in place, there is an obligation to follow.
Definitions, labeling and actions (including contracts) should be consistent.
 
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