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Alan VanHOUTEN

Quality

Alan VanHouten got his start working with interventional cardiology companies in 1996 as a quality engineer and later as a project engineer.  Alan is an experienced Senior Project Engineer with expertise in all areas related to bringing new single-use medical devices to market and into high volume production. Most of his background is working with Class II medical device companies and helping move into the commercialization phase and beyond.  In addition to his broad view of project management as it relates to quality production and system implementation, Alan will assist Radux Devices with details such as identifying specifications of mechanical components.  Alans key responsibilities include: process validation, developing a Quality system which is compliant with ISO 13485 & MDD, Risk Management Files and electrical safety certification 60601-1.  Alan is also a certified auditor for ISO 13485:2016. 

Alan has a B.S. Degree from Winona State University.