Linear Regression Analysis for Medical Device Manufacturing

Why Should You Attend:

Medical device manufacturers need to establish statistical methods to understand and improve process capability and product characteristics. These could take many forms, because there are a variety of techniques available. The application of the tools is not always clear. Incorrect choices, inadequate descriptions, or incorrect implementation can result in missed opportunities or, at worst, an FDA Warning Letter.

The guidance document, ISO/TR 10017:2003, describes statistical techniques and their applicability to a Quality Management System. While it uses ISO 9001:2000 as the basis, it is very easy to apply it the Quality System Regulation. One powerful technique, with wide applicability, is regression analysis.

This presentation covers two related tools. A graphical approach called a scatter plot and an analytical approach called linear regression. They combine to provide a picture of the data and statistical results for analysis that can help guide improvement.

While hand calculations, or even a calculator, can be difficult, MS Excel has a myriad of methods that make these tools easy to apply. Excel provides graphical techniques that can overlay the regression results on the plotted data. It also has built-in functions that provide the parameter values and statistical results needed for further analysis.

This presentation explains the techniques, illustrates them with examples, and demonstrates how to set up a spreadsheet that uses them.

Learning Objectives:

• Learn the device quality regulations’ requirement for statistical techniques
• Understand how ISO/TR 10017:2003 can help select statistical techniques
• Know the concepts that underlie linear regression
• Use the graphical methods in Excel that help visualize the data
• Learn the statistical functions in Excel that aid understanding and analysis, including the Slope, Intercept, Pearson, RSQ, Forecast, Trend, and LinEst functions

Areas Covered in the Webinar:

• Using ISO/TR 10017:2003 to identify statistical techniques
• The use of the scatter plot to display data and information
• Applying the quantitative methods of liner regression to the scatter plot
• Using Excel graphics to display regression lines and equations
• Using Excel functions to calculate the slope, intercept, and other values related to linear regression

Who Will Benefit:

This presentation is oriented for people who analyze data and use the results to understand and improve processes. This includes:

• Quality Managers
• Quality Engineers
• Verification Specialists
• Design Engineering Managers
• Design Engineers
• Data Analysts

Daniel O Leary
President, Ombu Enterprises, LLC

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 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 holds an APICS certification in Resource Management.

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