PhD
Product Development and Operations
Octavio (Tavi) Cruz-Uribe is both an Operations professional that has experience establishing small medical device companies and a Quality System expert in setting up 21 CFR 820 and ISO 13485 compliant quality management systems. He started in the industry over 14 years ago in large scale pharmaceutical manufacturing validation and compliance before moving over to medical devices. Since then he has worked with over 20 different medical device companies in fields ranging from active implantable devices to surgical guidance systems to disposable catheters. He has successfully submitted technical files, 510(k)s, and PMAs for new products and has successfully navigated multiple regulatory (ISO and FDA) audits for new companies. Presently he manages a small medical device company developing membrane technology to immobilize and deliver stem cells. He holds a PhD in Biochemical Engineering from Oregon State University and a B.S. in Chemical Engineering from University of Colorado. For more information, please contact Dr. Uribe at Tavi@biomdg.com