I'm starting off development of our QMS (we are pre-revenue medical device company) with trying to understand which procedures to be compliant with ISO 13485 are relevant to our situation.
My first thought is and sop related to "Measuring and monitoring equipment" would not be needed since we have a contract manufacturer for our product. Did I guess right?
If not, do I somehow have to refer to their procedures etc...?
My first thought is and sop related to "Measuring and monitoring equipment" would not be needed since we have a contract manufacturer for our product. Did I guess right?
If not, do I somehow have to refer to their procedures etc...?