Medical Device Reporting

July 22, 2016 9:45am

Stephanie Wasielewski
Corpak MedSystems, Inc.

Stephanie Philbin
Goodwin Procter (Washington, DC)

  • Handling of complaint files
  • What is reportable?
  • Generally applicable requirements for individual adverse event reports
  • Requirements for developing, maintaining, and implementing written MDR procedures, files, and records
  • Exemptions, variances, or alternative forms of adverse event reporting requirements
  • What information from the reports is disclosed to the public?
  • Does the information in my report constitute an admission that the device caused or contributed to the reportable event?
  • Common errors and how to avoid them
  • Identifying the latest trends in MDR
  • Warning letters or 483s at the end of an inspection
  • Hypotheticals