MDR Adverse Event Codes for Devicemakers - Webinar Recording/Transcript

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MDR Adverse Event Codes for Devicemakers

What devicemakers know is that MDR reporting is slated to change, with the old coding system going obsolete and new challenges arising to completion of Form 3500A.

What many devicemakers still don’t know — but need to — is that the FDA is ready to assist you, with a free downloadable tool known as eSubmitter.

All you gotta do is figure out how to use it … before the codes change.

And that’s where FDAnews comes in. Dan O’Leary, one of our top-rated presenters, introduces you to the new coding regimen and walks you through eSubmitter’s twists, turns and tricks. In a fast-paced 90 minutes, you’ll discover:

  • Criteria for a mandatory medical device report
  • Required records and their content
  • The reporting system and associated acknowledgements
  • When codes apply in eSubmitter
  • The IMDRF harmonization plan: Which parts the FDA has adopted
  • Selecting the appropriate codes
  • Transition dates: Avoiding FDA rejection of obsolete codes
  • And MUCH more!

Bonus Materials!

  • Summary of the changes and their implications
  • Links to the IMDRF project and to the FDA’s codes

Don’t put off figuring out eMDR submission and risk blowing the deadline. Get ready for implementation now, well ahead of the effective date, and gain crucial background that helps you implement the new coding system without a hitch.

Individuals involved in complaint management and adverse event reporting should sign up. In particular persons in the following job titles will benefit:

  • Quality Managers
  • Quality Engineers
  • Complaint Analysts
  • Adverse Event Managers
  • Medical Affairs Managers
  • MDR Investigators
  • MDR Preparers
  • MDR Submitters
  • IT Professionals who maintain eSubmitter

Dan O’Leary is President of Ombu Enterprises LLC, a company offering Operational Excellence training focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.