Medical Device Reporting - Webinar CD/Transcript
Medical Device Reporting: A Practical Approach to Pass an FDA Inspection
Do you dread MDRs?
Industry expert Dan O’Leary, President of Ombu Enterprises, LLC, explains MDR issues and provides advice on implementing an effective MDR system.
In 90 minutes he covers:
- The required content of your MDR procedures
- The reporting criteria for an MDR
- Special cases raised in the guidance documents, such as contract manufacturers
- When the initial MDR is due as well as any followups
- The current submission method — eMDR
- The records to maintain that demonstrate you submitted on time
- The effect of UDI on required records
- The connection between complaints and medical device reports
- Auditing the MDR process
Order today and learn how to implement an effective MDR system.