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Marcia Page joined Calypso® Medical in June 2002 with more than 20 years of experience in the medical device industry. As director of quality assurance, Ms. Page’s responsibilities include primary interface for FDA inspection and regulatory agencies, lead auditor for suppliers and oversight for Quality System Development and Compliance. Prior to joining Calypso Medical, Ms. Page was vice president of quality assurance and regulatory affairs for Plexus/SeaMED and corporate director of regulatory compliance and quality systems for Plexus Corporation, a contract design service provider for medical and complex high-tech products. Her responsibilities included ensuring compliance to the QS Regulation, ISO 9001 and EN 46001 for multiple business divisions in various geographic locations. While at Plexus/SeaMED, Ms. Page had direct involvement with the quality system through compliance auditing with government agencies and third party auditors. As a consultant with Noblitt and Rueland, a leading medical device consulting firm, she implemented compliant quality systems and identified and resolved problem areas for clients. Ms. Page attended Washington State University with a focus on business administration. She is a frequent instructor for the University of Washington Regulatory Affairs and Biomedical Certificate Program. Ms. Page is the past-president and current Device Co-Chair for the Organization of Regulatory and Clinical Associates (ORCA). | 