I'm trying to determine what level of traceability will be required for electronic components that form part of a Class 2 (in the US) medical device. The question is whether batch-level traceability, or manufactured-date traceability is sufficient without maintaining records to relate component reels or IC batch codes to final product.
I realize it's probably a matter of risk vs. economics, where if a lower level of tracebility is adopted, there's a risk of having to recall the entire production if something is wrong. But I'd be interested to hear your opinion, or that of your auditor or regulatory body.
I realize it's probably a matter of risk vs. economics, where if a lower level of tracebility is adopted, there's a risk of having to recall the entire production if something is wrong. But I'd be interested to hear your opinion, or that of your auditor or regulatory body.