The FDA is legally obligated to inspect manufacturers of medical devices in compliance with 21 CFR 820 QSR at regular intervals. Do not take any risk of receiving major findings or a warning letter from the FDA.
With an intensive gap analysis our employees reveal existing inconsistencies in your quality management and take the appropriate actions to comply with the Quality System Regulations 21 CFR 820th.
Our long standing experience in dealing with inspections and audit situations, our experts can selectively prepare your employees for the upcoming event and will offer you consultancy and practical support pre- and post-inspection.
Take advantage of our multiple successfully applied approach during the preparation, monitoring and evaluation of your FDA inspection.