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BIOMEDigital 2020 Session Viewer

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Tracey WielinskiSenior Vice President, Quality, Regulatory and Clinical AffairsCytrellis Biosystems, Inc.

Tracey is the SVP Quality, Regulatory and Clinical Affairs at Cytrellis Biosystems, Inc. with over 25 years of experience successfully implementing and maintaining Quality and Regulatory Systems in a diverse range of environments focusing on Regulatory Submissions, Global Clinical Trials and Development of Quality Management Systems.

Tracey is the founder of Qualtra Consulting Inc., a consulting service to the medical device industry. Prior to Qualtra, Tracey held several executive management positions with Abbott Laboratories, STERIS, Insulet Corporation and OMNI LifeScience. Tracey holds an M.S from Regis College (2007) and a B.A. from the University of Toledo (1992).


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