Agenda

1. Why Managing Mechanical Variation is Important to Breaking into the U.S. Med Device Market
   Speaker: Ed Walsh, Sigmetrix

   Why managing the variation for medical devices is important to break into the U.S. Med Device industry. Med devices are Sigmetrix's 2nd largest industry segment. Sigmetrix is currently serving eighty companies around the world.

   1. Introduction
   2. Considering variation throughout the product lifecycle vs waiting until verification validation
   Trends and how this may influence MedDev success
   References to variation in FDA 21 CFR Part 820.30, ISO 16142-1:2016, ISO 13485:2016
   Using FMEA/DFMEA and other processes to determine critical-to-function specifications
   How CAD and other engineering tools can create a false sense of security 3. Discussing and addressing variation across multiple functional groups in an organization
   Trends and how this may influence MedDev success
   Adopting a common “language”
   Scrap or deviation?
   4. Example Cases

2. Benefits of CETOL 6σ in the development of drive systems
   Speaker: Michael Morgenbesser, Austro Engine

3. Development of a Model-Based Method for Tolerance Analysis of High-Performance Engines
   Speaker: Salvatore Calasso, Automobili Lamborghini