Speaker Profile

Tim Stein

President, Business Performance Associates, Inc.

Tim founded Business Performance Associates, Inc., a consulting firm located in Cupertino, California in 1994.He has consulted with over 120 companies in software development regulatory compliance, quality systems, software submissions, and software validation. Tim has helped numerous companies achieve compliance with IEC 62304 through audits, gap analyses, training and implementation support.

Tim was the Director of Software Validation and Quality Assurance at Genomic Health. He is the author of: The Computer System Risk Management and Validation Lifecycle, 2006. Tim has made over 40 presentations at professional meetings and conferences and as well as webinars. He is an ASQ Fellow and a past chair of the Northern California Biomedical Discussion Group.

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