In the considered case we were asked to remediate the biocompatibility substantiation for an invasive device. The Notified Body had pointed that insufficient attention had been given to wear leachables related to mobile parts. In addition, cleaning validation was insufficient considered.
By documenting a Biological Risk Assessment, we helped the Client to synthetically review the various sources of contamination of the product, merging design-related aspects with process contamination.
In a second stage, Medidee experts reviewed the various possible tests with the test labs and documented the validation plan. The key was to select the right extraction methods, as well as choosing the right sample size.
Further to classic 10993-1 aspects, we also considered ASTM F2847 − 17 and NF S94-091 standard requirements.