Sigmetrix - Tolerance and Variation Analysis Software

While CAD part models are perfect, manufactured parts are guaranteed to have small dimensional differences due to variations in the manufacturing process. Those differences can lead to big problems during final assembly. Charles Fine, of MIT, once said, "The final assembly is the moment of truth". CETOL gives you the confidence of knowing how the assembly will perform prior to it going into production.

Tolerance and variation analysis technology

Sigmetrix's CETOL 6 Sigma, the premier tolerance and variation analysis technology in the world, provides a level of design control and system insight previously not available. This added insight is critical in robust product development requirements in meeting the quality standards (for example, FDA 21CRF Part 820) of the medical device market. This newly exposed design knowledge, enabled by CETOL, helps to minimize a product's performance and liability risk, which could unknowingly be introduced because of manufacturing part variation.

Design control and risk management of medical devices

Because of the unique regulatory requirements and significant liability issues inherent in the medical device industry, the more visibility an engineer has into the actual performance of the design after manufacturing, the greater his ability to control risk by design and minimize liability exposure.

CETOL 6 Sigma has streamlined the mechanical variation analysis process and allows multiple design scenarios to be evaluated early, easily and often, providing greater visibility and control of the impact of manufacturing part variation.

Medical device modeling, automated variation analysis and simulation

CETOL uniquely combines geometric, mathematic and kinematic modeling with automated variation analysis and GD&T simulation to provide a precise yet comprehensive level of understanding that is only available with CETOL. Combined with the ability to easily analyze the performance of the assembly through its entire tolerance range, CETOL gives you and others the ability to actually visualize, through animation, the potential impact that manufacturing variation has on the performance and robustness of a product.

Tolerance and variation analysis software for medical device manufacturing

CETOL 6 Sigma provides a comprehensive set of tools to intelligently guide the user to a very precise assembly model, allowing a very accurate prediction of critical variation impact. These tools include:

• Rich graphical interface and modeling wizards
• Precise sensitivity analysis combined with true sensitivity animation
• Analytical, statistical and worst-case tolerance analyses
• Rapid 'what-if' without re-simulation
• Interactive CAD model analysis visualization
• Clean, organized and highly interactive Tolerance Information Manager™ interface
• On-the-fly WYSIWYG report creation
• Comprehensive integration with Pro/ENGINEER, CATIA V5 and SolidWorks