MedTech Safety
Bio
Tina has over 40 years of industry medical device experience including IVDs, software, hardware, combination products, and implantable medical devices. She has led employees in research and development, clinical research, operations technical support, and has over 25 years of quality assurance experience in multiple quality organizations. Tina serves as an international expert on several ISO Technical Committees for IVDs, electrical equipment, post market surveillance and is co-chair of the US technical advisory group for the working group responsible for ISO medical device risk management standards. Tina has taught for Northwestern University Master of QA/RA program and teaches several AAMI University courses.
Tina received a Master of Science degree in Product Design and Development from Northwestern University, School of Engineering in 2006.
Tina currently provides consulting services with BioTeknica Engineering & Regulatory Services.