Medmarc

Webinar Details

Keys to an Effective Complaint-Handling System: How to Audit and Improve Yours

Previously Recorded on July 18, 2018

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:

  • How to perform a failure investigation and what documentation should be maintained
  • What guidelines employees should be provided about how and when to respond to complaints
  • How to investigate complaints when product has not been returned or samples are not available

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.