510(k) Change Analysis - Webinar Recording/Transcript

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510(k) Change Analysis: Key Takeaways from the Final Guidance

On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required.

We explain it all to you ... and outfit you with tools to comply.

Background: The 21st Century Cures Act mandates new guidances to replace protocols in place for as long as 20 years. One guidance is expected to cover general changes, the other changes specific to software.

Look for: A focus on risk management ... clarification of many issues including QSR in the analysis ... extensive use of flow-charts ... and changes to documentation protocols.

Top presenter Dan  O’Leary has followed this matter every step of the way. He is readying an Excel workbook that implements the logic in the flow charts, guides the user through the decision-making process, and shows the decision path if a new 510(k) is required.

This workbook will be yours FREE when you sign up for this presentation.

Get ready to discover:

  • The FDA’s plans for evaluation of changes
  • Role of risk management (ISO 14971:2007) in the evaluation process
  • The decision-making process embodied in the flow charts
  • The criteria behind the flow-chart decision boxes
  • How to establish the quality record to support your decision
  • And much more!

Remember, it’ll be a different world after Nov. 8. It’s on you to be in compliance, and any failure could delay getting changed products to market. There’s no point taking a risk.

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

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence via a systems approach to operations management. Mr. O’Leary boasts more than 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.