Company Info

  Home > Archived Webinars >

FDA Reporting for Medical Devices
FDA Reporting for Medical Devices

Our Price: $395.00

Product Code: WB6

Product Info
About the Product
Contains video file.

When it comes to possible health risks, transparency and cooperation with regulatory bodies is of utmost importance. Many manufacturers are confused about what to report to the FDA. What exactly does "significant" mean when it comes to MDR? Hear from an FDA expert on:
  • Relevant Contact Within the Agency
    • How to properly report
    • Adverse events
    • Design malfunction
    • Packaging/Sterilization errors
  • How to Prepare for a Subsequent Audit, Warning, or Recall


Casper E. Uldriks, JD, MDiv.
Associate Center Director Regulatory Guidance and Government Affairs
Center for Devices and Radiological Health


Share your knowledge of this product. Be the first to write a review »