How to Address Medical Device Sample Size Issues – Webinar Recording/Transcript

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How to Address Medical Device Sample Size Issues: What Regulatory and Quality Professionals Absolutely Must Know

More 483s are being issued for violation of 21 CFR 820.200, statistical methods — most often for a lack of statistical justification for sampling plans.

That’s why it’s more important than ever to understand the requirements for statistical techniques and how they impact your design-control process.

You can address your sample size issues. Design control statistical expert Steve Walfish is here to explain how.

During this presentation, he will develop a framework for justification. You’ll come away with a set of tools to help demystify statistical sampling plans.

Presentation Takeaways:

  • Appreciate the nuanced interpretations of 820.250
  • Recognize the differences between confidence and reliability in the sample size
  • Address actual issues faced by medical device companies through case studies
  • Understand the importance of how data is collected and how to justify the sample size
  • Incorporate statistical assumptions, such as independence, as part of all sampling plans
  • Grasp how variance in the opulation impacts the sample size necessary to establish objective evidence

Take control of your sample size issues! Learn how to use sound risk management techniques in combination with statistical methods and reduce sample sizes.

  • Quality Engineers
  • Product Development Engineers
  • Quality Assurance Managers

Meet Your Presenter
Steven Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. He has experience applying statistical methods to all phases of a product’s lifecycle, supporting development through post-market surveillance. Mr. Walfish is a member of the ISO TC69 Statistical Methods. He has given talks globally on the use of statistics for development, validation and post-market surveillance. He was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA-regulated industries.