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Medical Device, Warranty Influences Expected Service Life

#1
Currently working on the IFU/OM for a digital medical device that has an internal rechargeable battery. We plan on performing accelerated testing in the future, just not yet.
Although the expected service life is an input (let's say we wanted the ESL to be 6 years), the battery manufacturer claims a 3-year life on the battery. My understanding is that the expected service life of the entire device will now be 3 years due to the battery (since that is the shortest defined life of all the other components).

If the company offers a 6-year manufacturers warranty on the product, or more, does that warranty increase or influence the expected service life?

Thanks!
 
Last edited:

yodon

Staff member
Super Moderator
#3
My understanding is that the expected service life of the entire device will now be 3 years due to the battery (since that is the shortest defined life of all the other components).
I don't think that's correct. The service life is however long you believe the device will be in service. The service life can include, well, service; i.e., battery replacement. If, however, the device is inoperable after the battery dies AND is not replaceable, then that would limit the service life.

The service life defines how long you need to maintain records associated with the device. Warranty really has nothing to do with it but I don't think it would be proper to have a warranty period longer than the service life.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
The expected service life (from a regulatory standpoint) is how long you as the manufacturer can guarantee that the device is safe and effective (including the testing that confirms that time), and thus, how long you want to be legally responsible for the device.

You can include a requirement to change the b battery each 2 years to make sure that it reaches the 6 years, even if the battery reliability is less than the ESL.

Warranty is related to it in the case of the device design - you usually do not want to have a warranty that does not take into consideration the reliability of the device and components (for example, defining warranty as 1/3 of the component with less reliability or something like that is an usual business practice so as you do not go broke by having to change more devices than you should).
 


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