Consultant's Bio

Richard Fries, PE, CSQE, CRE is the President and Chief Consultant of ISORel. He is a licensed Professional Engineer in the state of Wisconsin and certified by the American Society for Quality as a Reliability Engineer and a Software Quality Engineer. He is also certified as a Six Sigma Green Belt, an ISO 900 Lead Auditor, and a TickIT Lead Auditor. He is trained as a Six Sigma Black Belt and a HIPAA Professional.

He has degrees from Loyola University in Chicago and Marquette University. He has 35+ years experience in hardware and software reliability, software development, regulatory compliance, and device design. He has developed software programs in C++, Access, PL/M, Fortran, and assembly language. He designed and developed a software-based device specification and validation tracking system. He is co-inventor of patent 5,682,876, entitled Absorber Switch Locking Device.

He has authored seven books and chapters in several others on reliability and regulatory compliance. One of the books is used for the senior design course in Biomedical Engineering at several universities in the United States and abroad. He has also written numerous articles in professional journals on hardware and software reliability, human factors, standards and regulations, and engineering education.

He is an ABET evaluator, having reviewed curricula at Arizona State, Michigan Tech, the University of Pennsylvania, Rutgers, and Georgia Tech. He is a Senior Life member of IEEE, a Senior member of ASQ, and a member of the Biomedical Engineering Society. He is a member of the IEEE Software Engineering Subcommittee. He was a member of the AAMI Medical Device Software Committee and the Technical Committees that developed ISO 13485 and IEC 62304. He is active on the Industrial Advisory Boards for Marquette, Vanderbilt, and Michigan Tech Universities. He was a member of the Vanderbilt University Engineering Research Council. He has guest lectured at Marquette University, Vanderbilt, and the University of Pennsylvania.