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To me an off the shelf serial to usb adapter is not a medical device.
(1) If a company wants to buy and stock this product for shipment to their customer, from regulatory and quality stand point what needs to be in place?
(2) Is there any impact to the cleared 510k for the device with which this will be used?
(3) If the company wants to stock this, what are the traceability, labeling and packaging requirements that need to be fulfilled?
(4) Are there any legal implications that one needs to be concerned with?
(5) If the product is bought off the shelf with no agreement with the manfacturer, what are the downsides from regulatory and quality stand point?
(6) Does this adapter become a Class II medical device, now that you use it with you Class II medical device?
Assumptions:
1) The adapter is off the shelf product and is CE marked
2) It has it own original packaging
3) The adapter has been tested and proven to work with your class II medical device
(1) If a company wants to buy and stock this product for shipment to their customer, from regulatory and quality stand point what needs to be in place?
(2) Is there any impact to the cleared 510k for the device with which this will be used?
(3) If the company wants to stock this, what are the traceability, labeling and packaging requirements that need to be fulfilled?
(4) Are there any legal implications that one needs to be concerned with?
(5) If the product is bought off the shelf with no agreement with the manfacturer, what are the downsides from regulatory and quality stand point?
(6) Does this adapter become a Class II medical device, now that you use it with you Class II medical device?
Assumptions:
1) The adapter is off the shelf product and is CE marked
2) It has it own original packaging
3) The adapter has been tested and proven to work with your class II medical device