Clearance and Approvals

The CRO Group assists in preparation and submission of premarket applications including 510(k) Premarket Notifications and PMA Premarket Approval Applications, as well as IDE’s,  513(g) determinations and DeNovo petitions to the United States Food and Drug Administration( FDA).

In Europe, the type of product for which you are seeking CE Mark  is addressed by regulations agreed upon by each of the Member States known as Directives and soon, the Medical Device Regulation or In Vitro Diagnostic Regulation (MDR & IVDR).

If your organization designs, develops, manufactures and or refurbishes what are regulated as medical devices or in-vitro diagnostics,  globally, a certified (also referred to as registered) quality system is often a regulatory if not market access necessity.