Tolerance Software for Medical Devices

Medical Devices -

It's All About Controlling the Design and Staying Out of the News!

Because of the unique regulatory requirements and significant liability issues inherent in many markets today, the more visibility a medical device engineer has into the actual performance of the design after manufacturing, the greater his ability is to control risk via the design and minimize liability exposure.

Sigmetrix’ CETOL 6 Sigma, the premier variation and tolerance analysis technology for medical device engineering, provides a level of design control and system insight previously not available. This added insight is critical for developing medical device products that are robust in order to exceed Quality standards over the life of the product. That newly-exposed design knowledge, enabled by CETOL 6 Sigma, helps to maximize product performance and minimize liability risk that could unknowingly be introduced because of manufacturing part variation.

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

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 in Design, Manufacturing, Quality, etc. the ability to actually visualize, through animation, the potential impact that manufacturing and assembly process variation have on the performance and robustness of a product.

CETOL 6 Sigma provides a comprehensive set of tools to intelligently guide the user through a very precise assembly modeling process resulting in a very accurate prediction of critical variation impact. Key features 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, on CAD model analysis visualization
• Clean, organized, and highly-interactive Tolerance Information Manager™ interface
• On-the-fly WYSIWYG report creation
• Comprehensively integrated with Pro/ENGINEER, CATIA V5, and SolidWorks