Med-tech companies must have systems in place that receive, investigate, analyze, and act on complaints from users, patients, and professionals. FDA’s Center for Devices and Radiological Health (CDRH) has recently put into place certain action plans in hopes of increasing and improving available information on postmarket device issues. Inspections are no longer implemented by the FDA to discover problems with marketed devices. Medical device companies must now increase their vigilance in gathering, analyzing and addressing problems with their devices in distribution or they may face costly product recalls.
In a new audio conference sponsored by Medical Device Daily, speaker Judith Andrews, PhD of Medical Device Consultants Inc., will educate listeners on prevention strategies, focusing on key concerns for the medical device industry.
The audio conference, “Avoiding a Device Recall: Customer Feedback and the FDA’s Postmarket Transformation Initiative,” is just $349 per listening site. It is scheduled for November 28, 2007, from 1 p.m. to 2:30 p.m. It includes presentation handouts and a half-hour Q&A session with the speaker. A CD (MP3 format) of the conference is also available. For more information or to register, call 800-688-2421 or 404-262-5474, and be sure to mention conference code T08481.