Overview
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
Why Should You Attend
Following the implementation of the results of a Human Factors/Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain why the FDA required a number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post-test participant inquiry is critical to validation success. we will describe how to do this. Handouts are usability validation tracking form, protocol form, and test results report form.
Webinar Takeaway
- Required number of participants
- Qualitative success criteria
- Choice of tasks to validate
- Post-test participant inquiry. Forms: Usability Validation Tracking Matrix
- Validation Protocol
- Validation Test Results Report will be given as Handouts
Who Will Benefit
- Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- HR Compliance
- Quality Management
- Risk Management
- Design Engineering
Faculty José Mora
Principal Consultant, Atzari Consulting, LLC
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time, he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
