Defective medical device expert witnesses analyze product design, manufacturing, labeling, and post-market performance to assess whether devices met safety and quality standards. They are often biomedical engineers, regulatory specialists, or clinicians who evaluate device failures, risk management, human factors, and compliance with FDA and industry requirements.
Medical Device Quality Systems Expert Witness
Medical Device Quality Systems Expert Witness
- Review Fee
- $300/hr
- Deposition Fee
- $375/hr
- Court Fee
- $400/hr
This expert has over 15 years of experience in the medical device industry as a quality engineer, quality systems and complaint investigator with emphasis on cardiovascular devices. A Certified Quality Engineer and Biomedical Auditor, his expertise includes managing quality systems, design and development of new product lines, product risk management and complaint investigations. He currently serves as Principal quality management systems and business Consultant for an independent consulting firm in both medical device and other industries. His understanding of medical device firm operations and intimate familiarity with medical device requirements in both the US and other geographies make him an ideal expert to provide advice in determining both legal and regulatory requirements for medical device firms as well as users (clinicians).
President and Principal Consultant, An Independent Consultancy in MN
Master of Business Administration (MBA), Argosy University
Minnesota