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Home > MEDICAL DEVICE EXPERT WITNESS
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| Our certified ISO13485 internal auditor has over 20 years experience helping medical device companies develop, test and manufacture products that comply with FDA and European CE regulatory guidelines. He founded the world's largest hypoglycemia symptoms alarm company while overseeing all engineering and regulatory activities. Often used in health care, Addison-Wesley published his book on artificial intelligence which has been translated into 1/2 dozen languages and sold tens of thousands of copies worldwide. We can help! if your needs include, |
- Technical legal discovery for products containing software,
- Independent assessment of product software quality,
- Regulatory Compliance,
- ISO 13485 and CE Marking
- FDA 21CFR Part 820
Software Quality Assurance & Test Consulting Engagements
| Rockwell Automation, Phoenix, AZ |
2011 to 2012 |
| Towers Watson, San Diego, CA |
2010 to 2011 |
| Northrop Grumman, Sierra Vista, AZ |
2010 |
| Abbott, San Diego, CA |
2009 |
| Giant Biosensor, Hong Kong & San Diego, CA |
2007 to 2012 |
| CSC Arabia, Riyadh, Saudi Arabia |
2006 to 2007 |
| Giant Medical, Minneapolis, MN |
2005 to 2006 |
| PulseTracer, Minneapolis, MN |
2004 to 2005 |
| Information Acumen, Minneapolis, MN |
2002 to 2004 |
| Pemstar , Rochester, MN |
2001 to 2002 |
| Medtronic, Minneapolis, MN |
2000 to 2001 |
Additional Experience
- Author of Data Mining: A Tutorial-Based Approach, Addison-Wesley Longman (2004)
- Adjunct university faculty instructor and guest lecturer on "Automated Systems Testing"
Education
- Master of Business Administration in Management, Golden Gate University
- Bachelor of Science in Computer Science, University of North Dakota
Certifications
- ISO13485 Internal Auditor
- Software Test Engineer
Contact us today at +1 (612) 877-1038 or click here to discuss your project.
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