Stryker selects SigmaQuest for FDA-level quality assurance

Stryker Endoscopy says it offers the first and only integrated arthroscopy resection system, Crossfire. This hybrid platform can operate both radio frequency (RF) and powered instrumentation from one console, company says.

SigmaQuest Inc., provider of on-demand, scalable solutions for product quality management, announced today that Stryker Endoscopy, a division of

The division is using the quality management software to track the quality of suppliers’ components. SigmaQuest software as a service helps with supplier quality management, according to SigmaQuest.

"Quality is paramount to our business along with adhering to the FDA’s Quality Systems Regulation (CFR21 part 820), which requires the tracking of external suppliers’ inventory," said Mazin Sabra, supplier quality engineering manager of Stryker’s Endoscopy Division. "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."

Nader Fathi, CEO of SigmaQuest commented, "Demand for SigmaQuest’s products in the medical device industry is continuing to grow as manufacturers are driven to ship defect-free products.

Sigmaquest provides data modeling calculators to estimate return on investment after matching SigmaQuest tools to your application.

onstrate compliance with FDA regulations ."

SigmaSuresuite of software leverages automatic data collection and powerfulroot-cause analysis to help users find, fix and avoid quality issuesthroughout products’ entire lifecycles, from the time products aremanufactured to when they are returned by a customer, should thatoccur, the company says.

Other Stryker Corp. products includeimplants for joint replacement, trauma, craniomaxillofacial and spinalsurgeries; biologics; surgical, neurologic, ear, nose & throat andinterventional pain equipment; endoscopic, surgical navigation,communications and digital imaging systems; as well as patient handlingand emergency medical equipment.

– Edited by Mark T. Hoske, electronic products editor, MBTwww.mbtmag.com

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