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.
Industry News
FDA's Sentinel Program Will Track Medical Device Performance Print E-mail
Industry News
Wednesday, 27 August 2008

The FDA's Sentinel Initative, launched August 11th for Medical Device Manufacturers, aims to track Medical Device Performance. According to HealthPointCapital :

The Sentinel program, launched in May, strives to be "a national, integrated, electronic system for monitoring medical product safety." The FDA is now in the process of initiating the orthopedic device arm of the program, which seeks to evaluate the performance of total hip, total knee, hip resurfacing, intervertebral disc implants and ankle devices of through the collection of registry data. This data collection process, per the FDA, should require minimal data transfer and protect patient privacy.

SigmaQuest's SigmaSure™ solution helps Medical Device manufacturers comply with the FDA's Sentinel Program.

 
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