Medical Device Reporting
What is it about?
- 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