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I work for a small manufacturing company that produces capacitors for medical and military customers.
I am not sure based on ISO 13485 (or FDA CFR 21.820) are we required to do software validation for our custom written softwares? Or the softwares written for the purpose of quality monitoring, ie. SPC software written in-house that are used as a part of production monitoring process.
I appreciate some feedback and help here!
I am not sure based on ISO 13485 (or FDA CFR 21.820) are we required to do software validation for our custom written softwares? Or the softwares written for the purpose of quality monitoring, ie. SPC software written in-house that are used as a part of production monitoring process.
I appreciate some feedback and help here!