Analytical Chemistry
Chemical Characterization of Materials
To aid medical device manufacturers who are under pressure to address increased and tightening perspectives to meet ISO 10993, Part 1 and Part 18 guidelines – with minimal impact on costs and timelines – WuXi AppTec has developed a chemical characterization and risk assessment program that bridges the gap between chemistry and biocompatibility.
Our team of toxicologists, materials specialists, biocompatibility specialists and chemists work with manufacturers to devise a testing program of material qualitative and quantitative analysis and toxicological evaluations that is specific to a product’s regulatory needs while anticipating the toxicological impact of the results.
A typical program would use the following “path” to get from chemistry to biocompatibility testing:
