Medical Device Reporting - Webinar CD/Transcript

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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.

Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • MDR Handling Specialists
  • Complaint Handling Specialists
  • Risk Managers
  • Data Analysts

Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including, aviation, defense, medical devices and clinical labs.