regulatory approval is a critical component to seizing first
mover advantage for medical device, biomedical and biotechnology products. Compliance with standards and
government approval is typically and unfortunately the “last
step” in the product development process. Success in Pre-Clinical
testing sets up the Validation testing and documentation
submission to the respective Regulatory agencies.
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. It’s not enough to select
a market based on extraneous information, only by conducting
in-depth market research aligned with a solid regulatory
strategy can a company realize its revenue goals with each target market.
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 President, Strohl Product Engineering. 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-8pm – Panel talk
with a moderator
Committee: Kryngle Daly, Patti 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!