Friday September 25, 2020 0 comments
BOULDER -- Boulder iQ has named Michael Andrews vice president of regulatory and quality.
“Mike is a skilled regulatory affairs professional with a doctorate in biophysics,” said Jim Kasic, chair and founder of Boulder iQ.
“His expertise and work in medical devices and biologics will take Boulder iQ’s regulatory and quality expertise to the next level.”
The company provides design engineering, development, turnkey manufacturing and sterilization services for consumer, high-technology and medical products, and regulatory, clinical and qualiity management system services for the medical device and in-vitro diagnostic (IVD) industries.
Andrews’ experience in quality assurance and clinical trial management includes work with Class III implantable and PMA (pre-market approval) devices, as well as class II therapeutic and IVD devices.
He spent six years with the Food and Drug Administration’s Office of Device Evaluation, where he coordinated the investigational device exemption program.
Most recently, he served as director of regulatory affairs for Viveve, Inc. (Englewood), where his work included the coordination of international product registration in Latin American, Middle Eastern and Asian countries.
Andrews has worked with companies including: Magellan Medical Technology Consultants (Minneapolis), as a strategic regulatory advisor; Kaztronix (Iselin, New Jersey), as a regulatory affairs consultant; Maetrics (Indianapolis), as a senior compliance and quality consultant; and Aesculap Implant Systems, LLC (Center Valley, Pennsylvania), as director of regulatory affairs and quality assurance.
Andrews holds a Bachelor of Science degree in physics from Michigan State University, and Master of Science and doctoral degrees in biophysics from Georgetown University.
He has served as a clinical assistant professor at the University of Colorado Health Sciences Center and a visiting assistant professor of physics at Alma College in Michigan.
“In today’s medical device world, regulatory and quality systems define the heart of market introduction and success,” said Kasic.
“Mike’s experience is already proving invaluable to our clients, and is making a palpable difference in their ability to get products to market and to the consumer faster than ever.”