Chris McLellan joined InnovaFlex Foundry in September of 2022 and brings more than 20 years of experience in FDA and ISO regulated Quality Systems Management and Regulatory Affairs.
Prior to joining InnovaFlex Chris was the Head of Regulatory Affairs for Philips Image Guided Therapy Devices (formerly Spectranetics) where he was responsible for US, EU, and Canadian regulatory strategy and compliance over the Coronary, Peripheral, and Cardiac Lead Management units. Prior to Philips, Chris has held roles in Quality and Regulatory at the engineering and leadership levels at companies including Viewray, Myoscience, Zeltiq Aethetics, Boston Scientific, and Cryovascular Systems.
Chris holds a Bachelor of Science in Industrial Technology from San Jose State University and is an MBA Candidate at University of Colorado at Colorado Springs. He has led several FDA negotiations and received market authorizations including the Bridge Vascular Occlusion Balloon, the TightRail Cardiac Lead Extraction dilator, and CavaClear IVC Filter retrieval laser which was a first in class device and received FDA’s designation as a “Breakthrough Technology.”
Chris lives in Colorado Springs with his wife and daughters, where he enjoys fly fishing, raising chickens, and playing ice hockey.
We are passionate about positively impacting our world by improving lives through high-quality products and services. Let’s change the world together.