As industry and regulatory bodies adopt the ISO 10993 Risk-Based Approach to Biological Evaluations, the demand for materials characterization studies increases.
And just as materials characterization plays a role in device design and development, extractables and leachables studies play a role in regulatory submission and preclinical safety testing.
WuXi AppTec works with you to first determine the best analytical approach for your medical device. We help you determine testing parameters, based on the device’s classification and indication for use (such as the intended population, route of administration and clinical application).
