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Steve graduated from the University of Minnesota with a Bachelor of Science in Electrical Engineering and an MBA from the University of St. Thomas.
Steve has 17 years experience in quality assurance and regulatory affairs
for the development of electronic products for the medical device industry
and the defense industry. For the past 12 years he has been managing
Quality Systems and product verification/validation activities for the
development and manufacturing of medical devices. The range of products
included Class II, Class III, active medical devices, non-invasive, invasive,
and sterile. Steve:
- Has extensive experience with product safety and EMC testing.
- Served on international standards development committees for product safety standards.
- Has given presentations on CE marking of medical devices and corrective action/preventive action (CAPA).
- Has significant experience with U.S. and international regulatory requirements.
Steve was recently named VP of Quality Assurance and Regulatory Affairs (July 2008), after serving for five years as Director of QA and Regulatory Affairs.
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