Medical Device User Experience Training
3-Day Class - $1795.
What will you learn?
Intensive and comprehensive discussion of FDA pre-market perspective, precedents & priorities for every topic presented in the course.
How the FDA Guidance, “Applying Human Factors etc” and IEC 62366-1 applies to your submission to the FDA.
HF Testing, test theory and test data, test processes, protocol development and summary reports.
Analysis of use-related risks and considerations of IEC 14971.
“How-to” identify critical user tasks and develop a Use-related Risk Analysis (URRA) from scratch that will be acceptable upon review.
In-class Formative testing, theory and practice using a sample medical device with IFU.
Group projects beginning with overall HF evaluation plan, identification of users, user groups, use environments, user tasks, task criticality, URRA, formative testing, simulated-use based HF/Usability (Summative) validation testing, data collection, analysis and evaluation of test data, and HF test report.
How to avoid vagueness and incompleteness in your submission
Is it for you?
Learn how to apply user-centered design and UX throughout the design process to make medical technology safe, effective, usable, and satisfying for clinicians and patients. Improve the quality of healthcare and prevent injuries and deaths due to medical error.
The training is for everyone involved in improving the usability or user experience of medical device products and/or software. UX designers, product managers, software developers, user acceptance testers, including those with no prior medical device experience. will benefit from learning this proven process .