European CABs (Conformity Assessment Bodies) now a reality - but are they worth it
This article was originally published in Clinica
Executive Summary
Is it worth paying to be audited by a European inspector to the US FDA's medical device regulations, or is it better to wait for a free audit from FDA inspectors themselves? Although European audits to the US regulations may only total some E3,000 ($3,000), which option is best for manufacturers?