The Food and Drug Administration (FDA) accepts MDSAP audit reports as a substitute for routine audits. However, specifically justified audits and follow-up audits cannot be replaced by MDSAP. It is also important to note that MDSAP is not valid for pre-market-approval audits (PMA applications), neither for pre-approval nor post-approval audits.
Successful certification is essential for the important US market. Incorrectly submitted applications lead to delays and can hinder sales in North America. We actively support you and point out the important points to save you unnecessary costs and time.
