|November 7, 2017 Meeting Featuring
A Panel Discussion
Usability Engineering: Reducing Risk and Improving Customer Experience for Medical Devices
Shannon E. Clark, PE
Principal, UserWise, Inc.
Sr. Test Engineer, TUV Rheinland of North America
Julia Choi, PhD
Human Factors Engineer, Intuitive Surgical
6:00pm - Brief Chapter Meeting
6:30pm - Light Dinner & Networking
7:00pm - Panel Discussion
Triple Ring Technologies, 39655 Eureka Dr, Newark, CA
$15.00 Advanced Registration until November 5, 2017
$20.00 At door (if space available - check/cash only)
|Shannon E. Clark, PE
Shannon Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with US and international regulations related to Human Factors.
Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.
Shannon graduated in 2010 from UCLA with a Bachelor of Science in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.
Arathi is a Medical Device Regulatory Compliance and Quality System Specialist at TUV Rheinland of North America, in Pleasanton, CA with over 16 years of experience.
Her background includes manufacturing, pharmaceutical, software and medical device operations, as well as professional consulting for FDA and IEC medical device regulations. She is a certified auditor for quality systems and a certifier for medical device safety standards. Arathi’s areas of expertise include medical device quality systems (ISO 13485, ISO 14971), software development process (IEC 62304), usability engineering (IEC 62366), and medical device safety standards (IEC 60601 series of standards). She has completed software verification & validation studies and design and human factors/usability studies. Arathi has certified more than 100 medical devices to IEC 60601-1, 3rd ed. Amendment 1 standards.
Arathi graduated with a Bachelor of Technology in Electrical & Electronics Engineering from TKM College of Engineering, India.
|Julia Choi, PhD
Julia Choi is a human factors engineer at Intuitive Surgical, with experience in usability considerations for instruments, accessories, systems, and the interfaces between, including data analytics to both inform and refine risk analysis, and contextual inquiry for design input. She also has experience in the development/design and validation of usable reprocessing instructions. In medical device development prior to human factors/usability, she has had experience in design engineering, clinical trials, quality engineering, and risk management.
Julia completed her BS in chemical engineering and graduate work in biomedical engineering (molecular imaging / cancer research) at UC Davis, holds regulatory affairs and quality engineering certificates (RAC / CQE), and has a keen interest in applying human-centered design approaches in both medical devices and in the community.
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