Tonight, we will walk through the regulatory process, defining the strategy that makes sense for various types of businesses, and then dive into how to pull it all together in an organized manner.
Janet Kwiatkowski is the President of MAE Consulting Services, LLC. An experienced Regulatory and Compliance Executive with a proven track record in the medical device industry. Recognized for creating effective cross-functional teams to bring products to global markets and develop regulatory strategies aligned with business plans. Successful achieving results through creative and innovation solutions. Janet received her B.S in Mechanical Engineering from Johnson & Wales University, her MBA from Nichols College and her Masters of Science Regulatory Affairs, Regulatory Affairs & International Studies.
Clair Strohl is a Senior Manager in the Engineering Sciences. He has more than 30 years of experience in medical product development both for major device manufacturers and several start-up companies. He has extensive experience in the new product development and manufacturing implementation processes and has coordinated safety and efficacy testing for submission to the FDA. He received a B.S in Electrical Engineering and an M.S in Biomedical Engineering from Drexel University, and an MBA in Finance from the University of Chicago. He has authored several technical papers, is a Registered Professional Engineer and holds a number of medical product patents for products actively used in clinical practice today.
Mike Drues, PhD is 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
Mike received his B.S., M.S., & Ph.D. degrees in Biomedical Engineering from
Iowa State University. He worked for & consulted with leading medical
device, pharmaceutical & biotechnology companies ranging in size from
start-ups to Fortune 100 companies. He also works 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.
5.30-6pm – Networking (registration and food)
6pm-7pm – Panel talk
with a moderator on “Mobile Medical Apps”
7pm-8pm – Pitch from
3 mobile medical startup companies (will confirm the names later this week)
Committee: Kryngle Daly, Patricia Durr, Ari Giaya, Alan Gonsenhauser, Andrew Halpert, Kartik Shah, Jerry Shapiro, Jeff Tingle
Committee Co-Chairs, Kryngle Daly, Jerry Shapiro
Thanks to past Chair, Ed Ross!