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We have a Supplier where we distribute their medical device branded with our name such as "Manufactured for MY COMPANY" We have been having an issue with part of the product in that we have been losing battery life because it has been activated at the manufacturer and due to handling and storage, sometimes the device's timed life has been depleted prior to usage by the customer. A suggestion has been offered whereby my company would activate the battery prior to sending it out to our customers, thus lessening the chance for early battery/device depletion. If we decided to pursue this route, the actual steps for my company would be 1. tear open the sealed plastic bag to access the device 2. activate the battery by turning on a switch on the device 3. applying a label over the switch to prevent customers from switching on/off the battery (the label contains some verbiage) 4. resealing the plastic bag that contains the device.
This is a class I device and it is not a sterile. Do the steps above constitute "manufacturing?" Would my company now be playing a role in the contract manufacture of this finished device? Would all of these steps need a DHR? Or, could we simply classify this as an activation of the product and be excluded as playing any actual manufacturing role? Thanks in advance.
This is a class I device and it is not a sterile. Do the steps above constitute "manufacturing?" Would my company now be playing a role in the contract manufacture of this finished device? Would all of these steps need a DHR? Or, could we simply classify this as an activation of the product and be excluded as playing any actual manufacturing role? Thanks in advance.