One of our devices requires servicing

[snoopy2017]

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.

 

[Ajit Basrur]

When you mention the term "manufacturer", do you mean the "contract manufacturer"?

 

[Ronen E]

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.

 

[snoopy2017]

manufacturer = original equipment manufacturer