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Human factors/usability testing of medical devices not only makes the product better by designing with the user as the focal point it is also an FDA requirement as part of the 510(k) or PMA submission.
If you are responsible for getting a medical device ready for market we have extensive experience in this area and have prepared a presentation to educate on how we can help your company and product. For further information or questions on our Usability Testing processes please contact Intersection-Inc.or direct contact Milt Halsted at 949-533-9352.
To create a premium service to help you meet your Usability and Usability Testing / cmc / IFU requirements, Intersection has put together the most experienced team of experts in California to address your needs. Our group is led by Dr. Joely Gardner, widely known in Human Factors & Usability Testing services (See link to her recent presentation on IFU Testing: http://www.thedesignacademy.com/#!joely-gardner-article/ip8). Dr. Gardner has a Certificate in Project Management and is a licensed psychologist and a Fellow and Diplomate in the American Board of Medical Psychotherapists & Psychodiagnosticians. She has performed extensive usability testing and voice of customer research projects for companies such as Mitchell Medical, ThermoFisher (Life Technologies), Quest Diagnostics Clinical Trials Division, and Cardinal Health. She is a part-time professor at California State University at Fullerton in the graduate-level certificate program in Customer Experience and User-Centered Design.