Warehousing two separate components to a finished device while meeting regulations

C

ChrisW

Starting to get Involved
#1
#1
Hello I am not sure where this falls but we have a rolling cart that an electrical control unit can be bolted to. The cart has no connections or electrical. The unit can be used without the cart but right now they are sold together but will be shipped in two boxes. We want to inventory the final device but don't want to have to label the cart as part of the final device so there are no warehouse mix-ups and when an order goes out they grab the serialized device and any finished cart on the shelf.

Any thoughts on how to do this easily and still meet regulations?

Thanks you
 
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I

indubioush

Ah ha!
#2
#2
When you say "device" do you mean medical device? Are you buying a medical device and distributing it as is without modification except for the cart switch? Are you a distributor, medical device manufacturer, or component supplier? What regulations apply to you?
 
C

ChrisW

Starting to get Involved
#3
#3
We are a medical device manufacturer. This device will control a catheter that is also manufactured by us. We fall under the Med Device regulations.
 
I

indubioush

Ah ha!
#4
#4
Assuming any cart can be used with any control unit...
When you receive medical device components, you check that the items meet your specifications. There is nothing wrong with having two different part numbers and specification documents for each of these items. When you receive and inspect the items, each gets its own lot number and part number and the paperwork will show traceability to the single order number. Then when your final device is shipped, your history record documentation needs to reflect the cart lot number that was used.
 
C

ChrisW

Starting to get Involved
#5
#5
Yes and that's the hard part because then the lot history technically wouldn't be closed until the item was shipped. These will be sold individually and not in lots either.
 
I

indubioush

Ah ha!
#6
#6
There is nothing that would prevent you from having a final kitting or shipping record. You can perform product release activities on the control unit and have it sit in your finished goods location. Then you will have a kit record that shows which control unit got matched with which cart when shipping. Do both items sit in their shipper boxes waiting to be shipped out? The customer assembles the control unit on the cart, correct?

A lot number can represent one unit.
 
C

ChrisW

Starting to get Involved
#7
#7
I realize that and that you need shipping records but I am not sure about the companies you have worked at but I always worry when the shipping department has to do stuff as they are always as stringent as many other departments in the company.
 
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