J
Jimmy Olson
Identification and Traceability - FDA Requirements
Seeking information on Identification and Traceability in Medical Device Tracking
Hello again everyone.
There has been a lot of rumblings around here in regards to identification and traceability in regards to FDA requirements. I am curious to know if we would need to apply this to everything we do, or if we can apply it to the specific medical products. We won't be manufacturing anything that would fall into the category of implant or life support, so my understanding is that we don't need lot traceability under the FDA requirements. But I might be off in interpreting that.
Any kind of clarification you can provide regarding identification and traceability would be greatly appreciated. We are currently trying to determine what we need to do and the scale of everything. Thanks.
Seeking information on Identification and Traceability in Medical Device Tracking
Hello again everyone.
There has been a lot of rumblings around here in regards to identification and traceability in regards to FDA requirements. I am curious to know if we would need to apply this to everything we do, or if we can apply it to the specific medical products. We won't be manufacturing anything that would fall into the category of implant or life support, so my understanding is that we don't need lot traceability under the FDA requirements. But I might be off in interpreting that.
Any kind of clarification you can provide regarding identification and traceability would be greatly appreciated. We are currently trying to determine what we need to do and the scale of everything. Thanks.
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