I am a highly experienced statistician and former Quality Assurance executive from the implantable medical device industry. I have led the Quality and Reliability programs for two leading producers of implantable pacemakers and automatic cardiac defibrillators through the product development, FDA approval, and production cycles.

I am also an expert at evaluating implanted device field performance using survival analysis of complaint and patient tracking databases. I have developed and managed CAPA systems, and have initiated and managed several medical device safety alerts.

If you are in the medical device business and need help in any of these or related areas, my experience and expertise are at your service!