Device Defect Training? - Personnel shall be made aware of device defects

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rick melton - 2007

#1
:) Hope someone can help? What does this mean and how do we meet the requirement: "As partof training, personnel shall be made aware of device defects which may occur from improper performance of their jobs"?

2. Does this mean just the product or does in include the customer? "In our case, it would be the patient or care giver?
 
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#2
rick melton said:
:) Hope someone can help? What does this mean and how do we meet the requirement: "As partof training, personnel shall be made aware of device defects which may occur from improper performance of their jobs"?

2. Does this mean just the product or does in include the customer? "In our case, it would be the patient or care giver?
If you are referring to 21cfr820.25(b)(1), it has nothing to do with customer training. It is the manufacturer's personnel as refered to in 21cfr820.25(a).

To meet the requirement, you have to include in your training, what the possible manufacturing defects are, so personnel know what defects to look for as well as what effect the performance of their work has on the safety and effectiveness of the device.
 
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