Stryker selects SigmaQuest for FDA-level quality assurance
Stryker's Endoscopy Division selects SigmaQuest SaaS for supplier quality management.
-- Manufacturing Business Technology, 7/14/2009 12:57:49 PM
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SigmaQuest Inc., provider of on-demand, scalable solutions for product quality management, announced today that Stryker Endoscopy, a division of medical device manufacturer Stryker Corp. has adopted SigmaSure software.
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.
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"As Stryker is a dominant player in this industry," Fathi continued, "it is exciting that it recognizes the value of our products. We are looking to continue working with this and other companies on internal and supplier quality management worldwide and to help demonstrate compliance with FDA regulations."
SigmaSure suite of software leverages automatic data collection and powerful root-cause analysis to help users find, fix and avoid quality issues throughout products' entire lifecycles, from the time products are manufactured to when they are returned by a customer, should that occur, the company says.
Other Stryker Corp. products include implants for joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment.
- Edited by Mark T. Hoske, electronic products editor, MBT www.mbtmag.com
