Data analysis is a critical function for process qualification and validation in medical device manufacturing. With multiple critical features and potentially thousands of data points to enter, analyze and report on, the opportunities for errors and delays can multiply quickly. In addition, the timelines that many manufacturers must work with leaves hardly any time to crunch the numbers! In fact, many suppliers and smaller device manufacturers lack the resources to process and analyze validation data. Macros and scripts can help automate this data analysis and common statistical software packages like Minitab and JMP can be customized to automate common tests. During this webinar attendees will learn see an example of typical statistical tests that are run during a process qualification in the medical device industry as well as a demonstration of a custom-built macro to handle these tests in Minitab.
Jack Wieland, Project Engineer, Lowell
Mr. Wieland joined Lowell in 2017. He holds a Master’s degree in Manufacturing Engineering from the University of St. Thomas, and a Bachelor’s in Chemical Engineering from the University of Minnesota Duluth. He is certified in ISO 13485:2016 Lead Auditor Training. Lowell provides precision machined orthopedic implants and instruments for spine, extremity, trauma and joint replacement.