One of our devices requires servicing



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.

Ronen E

Problem Solver
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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