This is a clip from a recent Q1 Productions Webinar on Medical Device Reporting of Adverse Events to the FDA. The webcast covered How to properly report: Adverse events, Design malfunction, Packaging/Sterilization errors and How to Prepare for a Subsequent Audit, Warning, or Recall. The speaker was Casper Uldriks, Associate Center Director Regulatory Guidance and Government Affairs at the Center for Devices and Radiological Health of the FDA. For the complete video visit: bit.ly or visit www.q1productions.com

See the article here:
FDA Medical Device Reporting of Adverse Events