AMA session on Special Controls with Mike Drues from Vascular Sciences

This weeks topic is over the FDA’s “Special Controls with Mike Drues.

Mike is the President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing , regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.

He received his B.S., M.S., & Ph.D. degrees in Biomedical Engineering from Iowa State University and has worked for & consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food & Drug Administration (FDA), Health Canada, the US & European Patent Offices, the Centers for Medicare & Medicaid Services (CMS) & other regulatory & governmental agencies around the world.

As an internationally recognized expert & featured keynote speaker, he presents frequently on cutting-edge medical technologies & regulatory affairs and conducts seminars & short-courses for medical device, pharmaceutical & biotechnology companies, FDA, Health Canada, US & European Patent Offices, CMS & other regulatory & governmental agencies around the world.

Mike is also a long-standing guest of the Global Medical Device Podcast where he discusses a broad expanse of industry-related topics from his experiences guiding companies through their regulatory challenges.

We hope you find this to be a valuable session that is able to help you with the challenges you are currently facing!