Statistical Solutions to Help You with the 5 FDA Medical Devices Stages

From bandages to pacemakers, medical devices have a single, primary purpose: to improve the quality of life. Medical devices companies must be responsible for the safety and effectiveness of their products throughout the entire product development cycle. In the U.S., the FDA recommends five stages for the device development process. These stages ensure the safety and efficacy of medical devices in the whole product development cycle, creating a need for rigorous pre-market trials and post-market surveillance activities to monitor the performance of medical devices. 

In this webinar, we will explore the stage goals and the statistical techniques typically conducted within each stage through examples of different medical devices. 

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Statistical Solutions to Help You with the 5 FDA Medical Devices Stages

Discover solutions to these challenges

You will learn from Ming Dong:

  •  The statistical tools that can help to ensure the safety and efficacy of medical devices in the U.S. based FDA’s device development process.
  •  The goals of each medical devices stage using used cases of different medical devices.
  •  Enable you to make informed decisions on how to improve processes, improve testing and validation to ensure reliability


Statistical Solutions to Help You with the 5 FDA Medical Devices Stages
FDA Drug and Device Development Processes
FDA Product Development Life Cycle


Ming Dong

Ming Dong

Minitab Technical Services Manager

Ming Dong is one of only a handful of practitioners across the Asia Pacific Region to be a certified trainer for Minitab’s flagship product, Minitab Statistical Software. The training certification process is the culmination of years of statistical training with real-life application of data analysis in the industry.

Ming’s formal qualifications include an undergraduate degree in Industrial Engineering Management, a Masters of Computer Science from the University of New South Wales, and a Masters of Applied Statistics from Macquarie University. With over 15 years of experience, Ming has a unique and profound understanding of the application of statistics in the business world.

In addition, Ming has broad business development experience, developed through his work in senior technical roles for large organisations such as Toshiba, OzEmail and National Computing Systems Singapore. As a university research officer at Macquarie University, he had several papers published in the field of Bioinformatics.

His extensive business development and industry experience are the reason why Ming has been engaged by some of the world’s largest mining, banking and medical devices companies, to provide consulting services in the application of data analysis.

Time remaining until webinar starts on Wednesday September 9, 2020.

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About Minitab


Combined with unparalleled ease-of-use, Minitab makes it simpler than ever to get deep insights from data. Plus, a team of highly trained data analytic experts ensure that users get the most out of their analyses, enabling them to make better, faster and more accurate decisions.

Minitab helps organizations drive cost containment, enhance quality, boost customer satisfaction and increase effectiveness. Thousands of businesses and institutions worldwide use Minitab Statistical Software, Companion by Minitab, Minitab Workspace and Quality Trainer to uncover flaws in their processes and improve them. In 2017, Minitab acquired Salford Systems, a leading provider of advanced analytics which delivers a suite of powerful data mining, predictive analytics and modelling capabilities.