Medical Equipment & Devices

Medical device manufacturers are often tasked with documenting the process to comply with regulatory requirements and improving quality to adhere to customer specifications. Failure to do not just one, but all of the above, is not an option in most medical device process scenarios. That's where capability analysis comes in. We invite you to explore how you can start today.

From bandages to pacemakers, medical devices improve quality of life. As a manufacturer, you are responsible for the safety and effectiveness of these products throughout the entire product development cycle. Explore how to pass these five stages to help you bring medical devices to the market.

When calibrating two measurement systems, orthogonal regression can determine whether the instruments or methods provide comparable measurements. Unlike simple linear regression, both the response and predictor in orthogonal regression contain measurement error. Using orthogonal regression, the medical device manufacturer can confidently conclude that their measurement instrument is equivalent to the current measurement instrument on the market today.

This 4-day track provides participants with the foundation for effectively using statistical methods to analyze, improve, and validate medical device processes. It is appropriate for process engineers, R&D team members, and other quality professionals who need to understand how to apply statistical tools to a medical device process.