US FDA inspections of medical device manufacturers: how to prepare and common myths

Michael Heyl (Hogan Lovells; MD, USA) helps medical device companies navigate myriad regulatory and business matters. He guides clients through US FDA regulations, requirements and compliance issues. These issues include FDA's Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as warning letters, defence strategies and corrective and remedial action plans. In this interview, Michael provides insights into the key steps a medical device company should take to prepare for an FDA inspection, emphasizing the importance of a strong internal auditing program. He also breaks down what typically occurs during and after an...