Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.
Allison is a former FDA reviewer whose expertise includes regulatory submissions, quality systems, and biocompatibility evaluation. She started AcKnowledge Regulatory Strategies, LLC in order to serve clients who manufacture implantable and other patient-contacting medical devices. She received her Ph.D. in Neuroscience from Stanford University, and her B.A. in Molecular and Cell Biology from the University of California, Berkeley. While working at FDA as a biologist and reviewer in the Office of Device Evaluation, she acted as a lead reviewer and consult on pre-submissions, 510(k) Premarket Notifications, Investigational Device Exemption applications, and Premarket Approval submissions. Her specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs in support of FDA recognized standards. Following her time at FDA, and before starting her own company, Allison worked as a project manager and regulatory affairs manager at an in vitro diagnostic device company, and as a senior regulatory specialist at a consulting firm. Working in close collaboration with her clients and FDA, Allison has helped clients achieve FDA approval for a diverse range of devices, including orthopedic devices, in vitro diagnostic devices, mobile medical applications, and neuro-stimulating devices.