Welcome to the Pacific Design & Manufacturing 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.
Jim is a seasoned RA/QA leader within the medical device industry, with over 30 years medical device experience. He has extensive experience with successful 510(k) and PMA submissions & clearances for various Class II and III products and experience gaining clearances in OUS countries (Canada, Korea, Singapore, Taiwan, Brazil, Australia, Thailand, China, Japan, Argentina, Mexico, Costa Rica, Colombia, Ukraine, Turkey, Middle East). He also has direct experience hosting FDA, notified body, and CE Mark audits (creating Tech File), complaint handling, medical device reporting, vigilance and post market surveillance across start-ups, mid-size and large medical device companies.