Reliability Program for Medical Device  
Author Julio Pulido




Abstract Medical manufacturing is becoming very complex and high technology oriented. The advanced technology inherent in medical devices and their production means that all aspects of the system–including mechanics, electronics, software and hardware–must be evaluated for reliability. However, the FDA evaluators rely on data derived from existing harsh environment standards and on manufacturers' own expertise, and neither of these risk management strategies foresees the issues specific to implantable medical devices. For a number of medical devices and systems, specific standards have already been put in place to exactly counter this situation. However, for implantable electronic devices, no general set of test standards currently exists. At the same time corporations are learning that Design for Reliability (DFR) programs do not work in an organizational vacuum. To be successful the program should be integrated into what is called an Advance Product Quality Process (APQP) or a Design for Six Sigma (DFSS) process [6]. This paper focuses on the required steps to develop a Design for Reliability Program from the ground up in an APQP or DFSS design environment and its benefits in terms of warranty cost and time to market.


Keywords Reliability Program, Testing, Design for Reliability
    Article #:  1994
Proceedings of the 19th ISSAT International Conference on Reliability and Quality in Design
August 5-7, 2013 - Honolulu, Hawaii, U.S.A.