Mark







Meet Our Team









Our Team of Experts - a Valuable Extension of Your Team


Whether you need assistance with a single assignment or someone to manage all your usability engineering efforts, UserWise’s team of highly trained human factors experts stand ready to support your medical device and combination product development. With diverse backgrounds in engineering and science, that include human factors, industrial, biomedical, and quality engineering as well as psychology, our team can rapidly onboard to your novel technology and company’s quality system to contribute valuable input to your program. UserWise human factors consultants have proven expertise in applying usability engineering best practices to medical devices and combination products across a wide range of medical disciplines and use environments.  

Leadership

Kelley Kendle
CEO
Shannon Clark
Principal
Denise Forkey
Director




Kelley Kendle

CEO




Shannon Clark

Founder & Principal

Licensing: Certified Professional Industrial Engineer

Education: BS Mechanical Engineering and a technical breadth in Technology Management

Experience: 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.

Fun fact: Shannon enjoys water skiing in the San Francisco Bay year-round (brrrrr!)


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