Medical Electronics Symposium Conference Proceedings


HOW TO ENSURE MEDICAL PRODUCT QUALITY IN A ZERO-TOLERANCE WORLD

Author: Nader Fathi
Company: SigmaQuest, Inc.
Date Published: 9/12/2006   Conference: Medical Electronics Symposium


Abstract: This is a case study of a leading medical device manufacturer (OEM), who needs to meet rigid FDA requirements for its Cardiac Pacemaker. We will highlight how this OEM addresses design, manufacturing, test and supplier challenges as well as how it meets FDA compliance in a globally dispersed environment. We will look at various solutions this manufacturer considered for providing real-time access to global data, as well as how it deployed a web-architected, global-product quality and performance-intelligence software system to ensures its product and process integrity. Keywords: medical device, test, visibility, reliability, FDA Title 21 CFR 11



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