Have the hermetic seals required for your medical product to remain aseptic been compromised during manufacture?
Have manufacturing steps such as welding unwittingly introduced blockages that prevent a device from functioning as designed?
Are your products sufficiently leak-proof such that contaminants are kept out permanently such that sterilization steps are not undone?
These questions and more must be answered and documented with a very high degree of certitude, not only to establish GMPs for regulators but also to ensure that your manufacturing operation is protected in the litigious medical industry.
And, for manufacturers of relatively low margin medical products such as check valves or plastic medical bags, the same attentions to production rates and bottom lines typical in other test-intensive manufacturing lines such as those making automotive products can’t be ignored.