Implementing the IMDRF Codes – Webinar Recording/Transcript
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Beginning September 7, the FDA will require devicemakers to use a new coding system and form for adverse event reporting. This most recent coding system was developed to improve, harmonize and expand the terminology and systems being used to code information relating to adverse events.
Join us to understand the new IMDRF codes and prepare for your Medical Device Reports (MDR).
The FDA is not alone in making changes to its MDR form. The EU implemented a new mandatory MIR form this past January. EU Notified Bodies expect manufacturers to have already implemented the new form as part of the vigilance process.
Dan O’Leary, President of Ombu Enterprises, will present on what you must know and do today and before your September 7 deadline.
- An introduction to the IMDRF code sets
- An explanation of the code set structures
- The planned changes to FDA’s reporting form
- The relationship between the IMDRF codes and the current FDA codes
- An explanation of the EU Manufacturer’s Incident Report (MIR)
- A description of the IMDRF codes used in the EU’s MIR
The IMDRF code deadline is near. Understand the new coding system and stay compliant.
Meet Your Presenter
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’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Masters Degree in Mathematics; 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.
Who Will Benefit
People involved in the inspection, measuring and test equipment (IM&TE) control program, particularly:
- Quality Managers
- Quality Engineers
- Production Managers
- Production Supervisors
- Manufacturing Engineers
- Production Engineers
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Aug. 20, 2020