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.
SigmaQuest CEO, Nader Fathi, to Speak on Preparing for the FDA Sentinel Initiative Print E-mail

Medical device manufacturers and others will gain powerful insight into preparing for FDA data queries

 

SUNNYVALE, Calif., September 10, 2009—SigmaQuest Inc., the leader of on-demand, scalable solutions for product quality management, today announced that company CEO, Nader Fathi will be giving a presentation titled, “Preparing Today for the FDA Sentinel Initiative:  Tracking the Performance of Medical Devices from Product Inception throughout Adoption by Patients” at the 2009 Medical Electronics Symposium. 

During the session, Mr. Fathi will share valuable information as to what the Sentinel Initiative (the upcoming national electronic system that will transform the FDA’s ability to track the safety of medical devices, drugs and biologics) means to medical device manufacturers and how best to prepare.  Attendees will learn how to prevent being caught off guard by FDA data queries via an automated process that tracks medical device performance and quality from the manufacturing phase throughout patient use. Mr. Fathi will also highlight best practices for ensuring supplier component quality, prior to product integration into medical device offerings.

Mr. Fathi is delivering his presentation along with several other panelists under Session 7, titled Reliability, Safety and Regulatory Testing. 

Event details:

Date: Thursday, September 17, 2009

Time: 2:00 – 2:30 p.m.

Location : Arizona State University, Old Main Building at the Tempe Campus

 

About the 2009 Medical Electronics Symposium

MEPTEC and the SMTA are joining forces to present the 2009 Medical Electronics Symposium: Drivers for Technology, Health and the Economy. This two day program will cover a broad spectrum of medical applications. This symposium will bring together business and technical experts from the medical electronics industry to give attendees current perspectives on the economic and industry trends as well as state-of-the-art technologies and medical applications.

 

About SigmaQuest

SigmaQuest Inc., is the product quality management on-demand leader.  The company’s SigmaSure™ is delivered as software as a service.  It combines automatic factory floor and return center data collection with powerful root-cause analysis to enable its customers to lower production costs and reduce product returns.  SigmaQuest customers are leading brand owners and manufacturers in medical device, telecom, military & aerospace, consumer electronics and cleantech energy sectors. The company’s market-changing approach has been recognized in Managing Automation’s Top Ten Companies to Watch, Manufacturing Business Technology’s Top 40 Emerging Vendors, Test & Measurement World’s “Best in Test” awards, and Supply & Demand Chain Executive’s “Executive 100” list.

 

The company can be reached at 408-524-3180 or www.SigmaQuest.com, and is located at 440 N. Wolfe Road, Sunnyvale, CA 94085,

 

SigmaQuest and SigmaSure are trademarks of SigmaQuest Inc. All other trademarks and registered trademarks are the property of their respective owners.