We have been handed a non-conformity against ISO10993 for Biocompatibility. The device is 316-grade stainless construction and is surely inherently biocompatible - the issue appears to be with manufacturing process chemicals which we had failed to consider.
How best would go about proving that chemical residues were removed (or reduced to safe levels) following manufacturer?
How best would go about proving that chemical residues were removed (or reduced to safe levels) following manufacturer?