SigmaQuest is the leader in on-demand scalable solutions for Product Quality Management. Our solution, SigmaSure, leverages a powerful root-cause analysis engine to improve product quality and customer satisfaction. Unlike home-grown systems and MES/ERP systems, SigmaSure is hardware and software agnostic - allowing you to automatically collect consistent data across the extended enterprise and perform detailed analysis on terabytes of parametric data.
Medical Devices Print E-mail
"Quality is paramount to our business along with adhering to the FDA's Quality Systems Regulations (CFR21 part 820), which requires the tracking of external suppliers' inventory." With SigmaQuest, we can more readily mitigate risk by identifying defective supplier components throughout the supply chain and ensure that their products perform to our specifications."
- Supplier quality engineering manager, Stryker

Electronic medical device companies manage extremely complex, life-saving products within a highly regulated industry. SigmaSure’s data collection and analytics tools enable you to capture product lifecycle component genealogy, and test data. The can use the test data to optimize product cost, improve safety, and mitigate liability risk.

 
 
 
SigmaSure key benefits to medical device companies:

  • Improve product safety with early warning system. Product failure is not an option for medical device companies. By providing an early warning system, SigmaSure enables you to identify and fix defects before they get into the field.
  • Drive down time and cost out of development cycle. SigmaSure collects and aggregates product test data from different locations and provides a real-time production quality picture for your worldwide team. This common view or "one truth" is used to communicate quality information across the extended enterprise.
  • Comply with regulatory requirements. SigmaSure product genealogy (traceability) function helps manufacturers meet stringent Food and Drug Administration (FDA). SigmaSure's real-time data capture and storage captures Device History Record (DHR) and helps companies meet FDA Title 21 CFR 11 and Good Manufacturing Practice (GMP) of product performance, quality and test results.

Webinar: What Medical Device Companies Should Know About Product Liability and Recalls


 
 
 
 
 

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