Ceram set to introduce regulatory approval service

Materials technology Ceram has launched a regulatory approval service designed to help hydroxyapatite users and manufacturers in the medical device industry gain FDA acceptance of their 510(k) submission.

The service includes a bespoke testing package that provides all the data needed to submit a master file to the FDA.

Using its range of analytical facilities, Ceram will produce credible, quality data and full documentation in support of the submission, backed up by technical support.