Internal Regulatory and Quality Advisor
David Vogel was the founder and president of Intertech Engineering Associates, Inc. from 1982 to the 2020 merger with Full Spectrum. Intertech had served the medical device industry by providing medical device development and validation engineering services for a large variety of device manufacturers. During that tenure, he participated in hundreds of medical device projects for clients. David was also an active participant with a joint AAMI/FDA workgroup to develop a standard for Critical Device Software Validation which was subsequently included in the IEC 62304 Software Lifecycle Standard. He worked with other joint AAMI/FDA workgroups to develop Technical Information Reports (TIR32:2004) for Medical Device Software Risk Management, and TIR36:2007 on the Validation of Software for Regulated Processes. As the author of Medical Device Software: Verification, Validation, and Compliance (2010, Artech Publishing), and as an AAMI instructor, Dave created and taught an AAMI workshop based on his textbook for nearly 10 years. David received a bachelor’s degree in electrical engineering and computer science from Massachusetts Institute of Technology, and from the University of Michigan he earned a master’s degree in bioengineering, a master’s degree in electrical and computer engineering, and a doctorate in bioengineering.<br />
Dave has been honored with an Outstanding Achievement Award in Biomedical Engineering from the University of Michigan, and was named as one of MD&DI Magazine’s “100 Notable People in the Medical Device Industry”.