|David A. Vogel, PhD|
David Vogel is the founder and president of Intertech Engineering Associates Inc. of Norwood, MA. Founded in 1982, Intertech has served the medical device industry by providing medical device development and validation services for a large variety of device manufacturers. Dr. Vogel and his Intertech engineering team have developed engineering processes that comply with design control regulations and guide their own development and validation activities. He was selected to participate with a joint AAMI/FDA working group to develop a standard for critical device software validation, which was subsequently included in IEC 62304, the software lifecycle standard. He was also a participant on the joint AAMI/FDA working group to develop a Technical Information Report (TIR 32:2004) for Medical Device Software Risk Management. Most recently, his work with the AAMI/FDA working group concluded in the development of TIR 36:2007 on the Validation of Software for Regulated Processes. A frequent speaker at trade events such as the MD&M Conference and Expo, Dr. Vogel received SB in electrical engineering from the Massachusetts Institute of Technology (MIT). He earned an MS in bioengineering, an MSE in electrical and computer engineering, and a PhD in biomedical engineering from the University of Michigan. He has been honored with an Outstanding Achievement Award in Biomedical Engineering from the University of Michigan in 2001, and was named in 2008 as one of MD&DI’s “100 Notable People in the Medical Device Industry.” He has been a member of MD&DI’s Editorial Advisory Board since 2006.