Medical Device Data Analysis Methods

8:00 a.m. – 8:30 a.m.

Continental Breakfast and Registration

8:30 a.m. – 4:30 p.m.

As a device manufacturer, you must analyze data for product improvement and to satisfy regulatory requirements in Quality System Requirements (QSR) and ISO 13485:2016. But are you completely clear on what the requirements are and, more importantly, what techniques to use?

This workshop identifies methods based on ISO/TR 10017:2003, which describes statistical techniques for a quality management system. While the standard describes methods, it does not provide implementation details. This, coupled with the fact that there are other methods available mean you need guidance on how to make your quality management system work to your best advantage.

Get the exact guidance you need to ensure your products remain viable. Statistical techniques covered include:

• Descriptive statistics
• Hypothesis testing
• Measurement analysis
• Process capability analysis
• Regression analysis
• Sampling
• Monte Carlo methods
• Statistical process control (SPC)
• Statistical tolerancing
• Time series analysis

During the session, receive data sets and descriptions so you can work on examples. The workshop does not use Minitab, because many small companies do not have it. Participants need to bring a computer, with the current version of MS Excel, to implement the necessary statistical techniques.

Dan O’Leary, President, Ombu Enterprises LLC

4:30 p.m.

Training Adjournment