Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.

This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.

This audio conference covers:

• Design control flow from user requirements to a medical device
• Regulatory requirements
• Statistical sample size methods
• How does the data type impact sample size?
• Setting the appropriate output requirements

About the speaker:

Steven Walfish is a statistician at GE Healthcare in Waukesha, WI. In this role Steven is responsible for data collection and analysis of complaint, nonconformance and audit data and metrics. Previously, Steven was President of Statistical Outsourcing Services, a consulting company providing statistical analysis and training to the FDA-regulated industries. Prior to starting Statistical Outsourcing Services, he served as the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville, MD.

Who should attend?

• Design Control Managers
• Quality Managers
• Design Engineers