FDA Compliant Quality System for Virtual Manufacturing (IVD Medical Device)?

J

jewel1130

#1
Hi all, I'm hoping you will have some ideas about this...

I'm setting up a quality system for a small company in the USA that is working on development of their first in vitro diagnostic device (instrument, reagents, software) with plans to market in Europe and the USA.

In this situation, we will be the primary developers and the legal manufacturer of the device, but we have no plans to actually manufacture any components at our company. All manufacturing of the instrument, reagents, consumables and software is being done by contract manufacturers under our control.

My question is, when setting up our required quality system docs/SOPs for this type of situation, would you implement corporate procedures like design controls, CAPA, trianing, complaint handling, etc but "skip" any procedures that don't apply to us because they are really manufacturing-type proceudres (for example, line clearance, product status tagging, incoming inspection, warehousing, etc) and just mention how you evaluate/select/monitor the suppliers? Or would you put some sort of a procedure in place that briefly mentions these topics and points to the CMOs? (I hope that make sense). Also, would you describe which activities are being specifically performed by CMOs in the quality manual?

Thanks!

Julie
 
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#3
I have seen both done. I think that you need to do what works for both you as a company and the contract manufacturer. One company I did some contract work for actually wrote all the manufacturing procedures and provided them to the contract manufacturer that way they had control over the process and understood and new what was suppose to be happening at all times. If you have hired the contract manufacturer one can only hope that you have audited them and reviewed their Quality Manual and feel comfortable that they can provide you with what you need on a consistent basis. I hope this helps a little.
 
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