Human Factors and Design Controls for Medical Devices and Combination Products
By Adam R Shames Presented by: Michael Gross, Ph.D. , RAC of Chimera Consulting North America LLC in collaboration with Adam R. Shames, MBA of Core Human Factors, Inc. May 27-28, 2015 Chemical Heritage Foundation Conference Center 315 Chestnut Street Philadelphia, PA 19106 Through interactive classroom lectures, discussion of case studies and sharing of experience, this advanced training, covering medical devices and device-containing combination products, is intended to enhance participant understanding of: Optimizing your company’s human factors design process through optimized design validation practices that can be applied to every development project in order to reduce development delays and improve the chances of first-time approval. How to utilize human factors studies, to identify design flaws, potential use errors and their mitigations, during development of a new device or device constituent part of a combination product, or when modifying an existing device