In this webinar, seasoned regulatory attorney Edward C. Wilson, Jr., Partner at Hogan Lovells’ Washington, DC, office, details what an effective complaint-handling system looks like for a medical device company, explains how to measure the effectiveness of such a system, and provides improvements for areas that may be lacking.
Attendees will learn:
Edward (Ted) Wilson, Jr., Partner, Hogan Lovells - Whether you're a multinational corporation or a growing business looking to expand in the U.S. market, complying with the FDA's web of medical device regulations can be challenging and resource intensive.
There's heightened scrutiny on everyone, and the consequences of not following the rules are substantial. Get it wrong, and you could face warning letters, civil monetary penalties, injunctions, product seizures, criminal liability, difficulty closing deals, and damage to your reputation. Ted Wilson has over 25 years of experience in assessing business and legal risks of regulatory compliance issues and finding ways to mitigate such risks.
Ted has helped companies of all sizes find workable business solutions to complex post-market compliance issues. Whether it is responding to FDA inspectional observations or a warning letter, assisting in the defense of a criminal investigation, conducting an internal investigation of alleged regulatory violations, executing product recall strategies, or interpreting the FDA's complex adverse event report and advertising and promotion requirements, Ted helps navigate the complicated regulatory environment in which medical device companies that market products in the U.S. must operate.