Regulatory Approval Testing of Hydroxyapatite - The Benefits of Using One Supplier
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.
Post-regulatory approval testing is also important, not only to confirm that regulatory standards are continuing to be kept but also that consistency, quality and performance are being maintained.
In this white paper we look at the case for using one supplier for regulatory approval testing, using the example of hydroxyapatite testing.
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