T
Dear Cove,
Currently working in the service department of a major medical device manufacturer,(under both 13485 and FDA rules)I have a question related to required planned maintenance routines for this equipment.
My company has a set of planned maintenace routines for our equipment both with respect to how often and what should be checked on scheduled maintenance. This maintenance is done by representatived of my company, not by the hospitals themselves.
When customers buy our equipment, it belongs to them [the hospitals] right?
So my question is to what extend must the hospitals (customers, end users) comply with these procedures of planned maintenance? Can the manufacturer "force" the customer to set aside time for this? If the customer would skip a planned maintenance are they allowed to?
Our regulatory dept clearly says no, however, I am in doubt since the equipment really belongs to the customer right?
any thoughts?
regards
t.
Currently working in the service department of a major medical device manufacturer,(under both 13485 and FDA rules)I have a question related to required planned maintenance routines for this equipment.
My company has a set of planned maintenace routines for our equipment both with respect to how often and what should be checked on scheduled maintenance. This maintenance is done by representatived of my company, not by the hospitals themselves.
When customers buy our equipment, it belongs to them [the hospitals] right?
So my question is to what extend must the hospitals (customers, end users) comply with these procedures of planned maintenance? Can the manufacturer "force" the customer to set aside time for this? If the customer would skip a planned maintenance are they allowed to?
Our regulatory dept clearly says no, however, I am in doubt since the equipment really belongs to the customer right?
any thoughts?
regards
t.