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“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,” says 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.”
“Demand for SigmaQuest’s products in the medical device industry is continuing to grow as manufacturers are driven to ship defect-free products,” says Nader Fathi, chief executive officer of SigmaQuest. “As Stryker is a dominant player in this industry, 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.”
For more information, call (408) 524-3180 or visit www.SigmaQuest.com.