Component supplier electrical test requirement - Obsolete Components

A

Allan66

#1
In the absence of a customer-supplied specification, is there any official document (FDA / ISO) which mandates that a supplier needs to maintain electrical test capability for supplied components after those components have been made obsolete by the supplier?

(Component is used in a Class III application).
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#2
Does the component have a shelf life associated with it? I assume not. I'm not a medical device person, so I can't answer definitively, but I would assume that unless the plan is to retest prior to shipment there wouldn't be a need to maintain electrical test capability.
 
M

MIREGMGR

#3
In the absence of a customer-supplied specification, is there any official document (FDA / ISO) which mandates that a supplier needs to maintain electrical test capability for supplied components after those components have been made obsolete by the supplier?

(Component is used in a Class III application).
Nothing on the FDA side. It's up to the customer to specify and/or control as they require.
 
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