MDR Procedures - The Required Content

Duration: 60 Minutes
All medical device manufacturers marketing in the United States must have procedures for reporting adverse events to the FDA. This applies regardless of where in the world the company manufactures the device. During an FDA Inspection, the investigator will ask for the procedures and verify that they follow the regulation. This includes linking the MDR information to complaints and reporting to FDA. Failure to implement the MDR regulations properly is one of the most common problems cited in Warning Letters. It comes just below the complaints and corrective and preventive action, both of which are often related.
MDR procedure
Instructor: Daniel O'Leary
Product ID: 506897
This presentation provides the framework to understand the most common MDR problems: procedures, reporting, and records. The regulation has a section for each area that states the requirements; the presentation explains them. In addition, the presentation covers the role that complaints play in managing the MDR process.

To help understand the requirements for procedures, the presentation uses the most commonly cited problems in Warning Letters. FDA often uses “stock” language to point out these deficiencies, so identifying these common problems can help make your procedures better able to pass an FDA Inspection.

Objectives of the Presentation
  • Learn the required content of your MDR procedures
  • Analyze the reporting criteria for an MDR
  • Understand special cases, such as contract manufacturers
  • Learn the timing for an initial MDR and any follow-up
  • Review the required records for an eMDR submission
  • Learn the impact of UDI on the MDR requirements
  • Understand the linkage between complaints and MDRs
  • Understand auditing as a preventive measure
Why should you Attend
Because MDR implementation is one of the most frequently cited areas in Warning Letters, the conclusion is that most companies don’t have a good understanding of the requirements. This presentation, with its analysis of Warning Letter citations, provides the information you need to ensure your implementation robust, and will pass Inspection.

Who will Benefit
People in the following roles can especially benefit from the knowledge in this presentation:
  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • MDR Handling Specialists
  • Complaint Handling Specialists
  • Risk Managers
  • Data Analysts
Bonus
Attendees receive a checklist based on the MDR regulation, Guidance Documents, Warning Letters, and QSIT to help ensure compliance.
$375
Recorded Session for one participant
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Instructor Profile:
Dan 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 aviation, defense, medical devices, and clinical labs. 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.
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