Gaining and maintaining regulatory approval of medical devices and materials, such as Hydroxyapatite (HA) can be a fraught, lengthy and complex process. Submission of data to regulatory bodies, for example the FDA (Food and Drug Administration), has to be credible and fully documented in order to ensure success. In the regulatory approval white paper, Gemma Budd, Product Manager, Healthcare at Ceram, argues the case for using one supplier for regulatory approval testing, using the example of HA testing.
The other white paper looks at various synthesis methods of HA, including precipitation, sol-gel and self-propagating combustion and demonstrates the vast variability of HA synthesised by some of the most popular methodologies.
With its newly-patented technology, Ceram’s aim is to work with clients to develop HA with tailored bioactivity, both for bone replacement materials applications and for new drug delivery systems with tailored bio-application requirements.
The white papers are free to download from Ceram’s website at www.ceram.com/medical.