Biography:

Edwin Waldbusser retired from the industry after 30 years in management of the development of medical device products and the development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems, and inhalation devices. His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control, and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis, and human factors analysis.

Ed has a B.S. Mechanical Engineering from NYU and an M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.