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Validity : 21st Oct'21 to 31st Oct'21
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.
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
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 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.
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences 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. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.