510(k) Change Analysis – Webinar Recording/Transcript

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510(k) Change Analysis: Make the Guidance Documents Work for You

The FDA’s 510(k) design change guidance documents are not the easiest to understand and incorporate. While the guidance’s flowcharts were designed to help guide evaluation and decision-making, they can instead be confusing. This presentation will provide you with a clear understanding of the decision paths and processes presented in the guidance documents, the information you need to write a solid SOP and the tools for effective implementation — helping you to stand up to an inspection.

Presentation Takeaways:

Industry expert Dan O’Leary, President of Ombu Enterprises, LLC, will present information on the guidance documents, including:

  • The role of risk management (ISO 14971:2007) in the evaluation process
  • The decision-making process embodied in the flowcharts
  • The criteria behind the flowchart decision boxes
  • How to keep quality records that support your decision


Bonus material! You’ll receive an Excel workbook, that implements the logic in the flowcharts, guiding you through the decision-making process and enabling you to provide sufficient documentation.

This presentation will show you how to develop a well-reasoned decision-making process and appropriate documentation to help avoid a 483.

  • Design Engineering Managers
  • Design Project Managers
  • Design Engineers
  • Quality Managers
  • Quality Engineers
  • Documentation Specialists
  • Regulatory Affairs Specialists

Dan O’Leary is the President of Ombu Enterprises, LLC. He 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.