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JJLit
I was just informed from one of our suppliers that they will be moving their operations into a facility that is owned by their parent company. This supplier provides a critical cobalt-chrome porous coating for several of our medical devices. This process was part of our 510(k) submission for this device. We are both FDA and ISO 13485 certified.
My question is what should I expect this supplier to provide as evidence of validation once the move takes place? Obviously we will be doing a vendor audit but I don't know what to request of them. I am sure they will put together a validation plan as part of their move and that should evaluate all risks that are associated. Are there some guidelines that I should follow?
My question is what should I expect this supplier to provide as evidence of validation once the move takes place? Obviously we will be doing a vendor audit but I don't know what to request of them. I am sure they will put together a validation plan as part of their move and that should evaluate all risks that are associated. Are there some guidelines that I should follow?