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Statistical Techniques for Medical Device Manufacturers

Tuesday, Dec. 15, 2020 • 10:00 a.m. - 4:30 p.m. EST | Presented by FDAnews and Ombu Enterprises

Want to upgrade your quality management system’s (QMS) efficiency and make it more effective?

While regulations don’t require you to use statistical techniques, the companies with the most robust QMS employ them regularly. And you don’t need to be a statistician to benefit.

This virtual workshop will cover the core techniques devicemakers most commonly require, how to choose and apply them correctly, ensure data integrity and interpret the output, so you can bolster your QMS and increase the likelihood of getting FDA approval or a CE Mark.

Dan O’Leary, President of Ombu Enterprises, chose the techniques based on ISO/TR 10017:2003, which describes statistical techniques for a QMS. He’ll also touch on other methods available, so you’ll get the guidance you need to make your QMS work to your best advantage. Dan will include the regulatory requirements from both QSR and ISO 13485:2016, and he’ll share real-life warning letters to illustrate problems encountered by devicemakers.

You’ll come away from this virtual workshop understanding the core statistical techniques most commonly required for your QMS, why they apply, how they work — without too much math! — and how to implement them in Microsoft Excel. While there are specialized statistical software packages available, Excel easily handles the core methods you’ll need, everyone already has it (it’s hard not to have Excel) and most are already familiar with it. In this way, the focus won’t be on software or calculations but on correct application, data integrity and understanding the results.

Just have a basic understanding of Excel formulas and medical device regulations. It would be helpful to bring a set of descriptive statistics, too. Dan will provide the rest, sharing:

  • Introduction and Basic Statistics
  • Summarizing Data with Statistics
    • Probability Distributions
    • Graphical Methods
  • Understanding Data Over Time
    • Run Charts
    • Time Series Analysis
    • Statistical Process Control Charts
  • Data Modeling
    • Regression Analysis
    • Predictive Analysis
    • Shelf Life Estimation
  • Measurement Analysis
    • Measurement Uncertainty
    • Measurement System Assessment
  • Acceptance Sampling
    • Attribute Methods
    • Variables Methods
  • Hypothesis Testing

Move your QMS light years ahead of your competition with these statistical techniques. Join us by registering today.


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Who Will Benefit

  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers

Meet Your Presenter

Dan O

Dan O'Leary


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 medical devices and clinical laboratories. He has a masters degree in mathematics and is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt.

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