Tom is a Quality and Regulatory expert. He has been a leading provider of quality and regulatory consulting services to medical technology companies around the world for the last 25 years. During this time, Tom has led the design and implementation of quality management systems at numerous companies, achieving registration to ISO 9001 and ISO 13485 and compliance with numerous other related standards. Tom has also guided remediation efforts at multiple companies to successfully resolve FDA 483s, Warning Letters, and Consent Decrees.
Tom has led St. Paul Consulting, a quality and regulatory consulting firm based in the Twin Cities. He has also founded and led two other startup companies. Most recently, Tom held leadership roles within Danish medical device manufacturer, GN Otometrics. He started as the Director of Global Regulatory Affairs/Quality Assurance and later became the General Manager of the company’s Canadian Operations. Tom was responsible for all aspects of the business in Canada, including product development, sales and marketing, quality, regulatory, operations, finance, and manufacturing.
Tom earned his Bachelor of Science in Business Administration from the University of Wisconsin-La Crosse.