DAY 1 | 8 AM-5 PM
Introduction and Overview FDA/CDRH Pre-Market Review Perspective
Preliminary Analyses for Pre-Market Approval
Formative Evaluation and Design Modification
DAY 2 | 8 AM-5 PM
Human Factors Validation Testing
HF Usability Report
Case Study I
DAY 3 | 8 AM-5 PM
Overview of Human Factors Medical Device Standards
Case Study II
Validation Design Exercise
A basic foundation for applying human factors will be set, with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.
All course faculty has completed an instructor training program. On-going peer and participant evaluation ensure consistency and quality from course to course. The faculty team for each program includes a lead instructor and an industry expert(s).
This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have a working knowledge of the Quality System regulation and design controls.
A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.
Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.