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Juergen WelteISO 13485 ExpertManex Consulting

Juergen Welte, earned his Graduation (B.S. equivalent) in Electrical Engineering from the University of applied science in Darmstadt, Germany.

Some of his next stations included the work on electrosurgical units in the Engineering and Design Department of a mid-sized German medical device compnay, before joining TUV Bayern (TUV Product Service) in Munich as a test engineer and expert for electro-medical equipment and later on in 1993 as an auditor.

In 1993 Mr. Welte transferred with the company to Tokyo, Japan and audited companies in Japan and other Asian countries according to EN 46000, ISO 9000 and the directive 93/42/EEC.

His work lead him in 1999 to the U.S.A where he continued working as an auditor; first with TUV Sued and then with TUV Rheinland of North America, Inc.

In 2004 Mr. Welte worked as a Lead Auditor for the Ultrasound Division of Siemens Medical Solutions USA, Inc. before re-joining his TUV roots in 2007.

From 2009 to 2018 Mr. Welte was working for TUV Rheinland of North America, Inc. out of the Pleasanton office as a Lead Auditor and Certification Officer for Medical Devices.

Since 2018 he is working as an independent consult specialized in regulatory affairs and quality systems for medical devices.