Detroit, MI 48202
You're invited! The WSU Technology Commercialization Office sponsors the "Conversations on Commercialization" series aimed to spark insightful discussions related to entrepreneurship, research and commercialization. Guest speakers with extensive entrepreneurial experience are invited to lead the discussions and share some of their wisdom related to bringing innovative technologies to market.
The next session,"Translational Medical Device Development - FDA Requirements: An Executive Overview," is scheduled for Tuesday, March 28th from 8:30am-10:00am at 5057 Woodward, 6th Floor, Conference Room A.
Kay Fuller, RAC, will be joining us to provide an overview of the FDA medical device design control process, geared for academic device development teams. We will discuss FDA 21 CFR Part 820.30 requirements for designing, developing and testing "pre-clinical" prototype medical devices, using a stage-gate approach.
Tips for meeting FDA engineering documentation requirements throughout the translational "bench-to-bedside" iterative development process will be provided. We will also review the preliminary performance and safety related testing that must be conducted on a medical device, prior to its use in a US-based clinical trial.
Kay Fuller, RAC
Medical Device Regulatory Solutions™
Global Regulatory & Clinical Research Consultants
Ms. Fuller is President and Founder of MDRC, LLC and has more than 38 years of industry experience developing and commercializing complex cardiovascular, neurosurgical, endoscopic imaging and drug delivery devices as a Regulatory Sciences professional. She has led successful global clinical studies and regulatory marketing authorization submissions for more than 36 Class II & Class III medical devices and combination products, via the U.S. FDA IDE, IND, 510(k), PMA, HDE and European Union CE mark processes. Under Ms. Fuller’s leadership, the firm has grown from a part-time consultancy in 2007 to a full-time, full-service regulatory and clinical research consulting firm.