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Presenter

Shannon Clark
Biography
Shannon has more than 10 years of experience in medical device and combination product human factors engineering, design, risk management, Verification and Validation, CAD modeling, training program development, marketing, compliance, and auditing quality systems. At UserWise, she works with medical device and combination product companies to develop strategy and answer regulator questions for human factors submissions domestically and globally and regularly participates on projects as a subject matter expert. Shannon currently sits on the IEC Standards Committee and is actively involved in developing and refining international human factors standards and has led training seminars at the FDA. Shannon is the co-lead investigator on the FDA (CDER) Training Decay grant with UserWise and San Jose State University. Before founding UserWise in 2014, Shannon was a Human Factors Engineer at Intuitive Surgical focusing on complex robotic surgery systems, and at Abbott Laboratories focusing on combination products.