My Services

Quality & Statistical Consulting for Medical Devices

What I can do for you

As a statistical consultant and former Quality Assurance Executive from the medical device industry, I will work closely with you and your staff to find cost-effective solutions to the statistical or regulatory challenges you may be facing.

I offer you the benefit of my years of experience performing statistical analyses and managing Quality Systems in an FDA regulated environment. If your issues involve adequacy of complaint investigations and CAPA compliance, I am highly experienced in this area as well.

· Clinical Trial Design and Sample Size Determination

· Detection of Failure and Defect Trends for CAPA

· Life Cycle Stress Fatigue Test Design and Analysis

· Longevity Forecasting for implanted devices

· Medical Device Recall Planning

· Quality Systems Review

· Reliability and Failure Rate Prediction from field performance data

· Statistical Methods in Process Validation

· Tools & Training for Statistical Quality Control

· Warranty Cost Projections