Medical Device Reporting

July 28, 2017 10:45am

Kevin Madagan
Partner
Reed Smith LLP (Washington, DC)

Stephanie Philbin
Counsel
Goodwin Procter LLP (Washington, DC)

Stephen Terman
Principal
Olson Frank Weeda Terman Matz, PC (Washington, DC)

  • Requirements for developing, maintaining, and implementing written MDR procedures, files, and records
  • Handling intake of complaint files and determining what is reportable
  • Generally applicable requirements for individual adverse event reports
  • Exemptions, variances, or alternative forms of adverse event reporting requirements
  • Identifying what information will be disclosed to the public
  • Staying conscious of including admissions that the device caused or contributed to the reportable event
  • Common errors and how to avoid them
  • Identifying the latest trends in MDR