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Gross, M., Shames, A. (2016). Quality & Systems Usability Requirements For Drug Delivery Devices & Systems. In this article, Michael Gross, PhD, RAC, Principal Consultant, Chimera Consulting, and Adam Shames, MBA, Chief Executive Officer, Core Human Factors, discuss US FDA quality system requirements for combination products, especially Design Controls, which includes the requirement to validate the design of the medical device constituent part of a combination/borderline product.

Click here to download a copy of the presentation (PDF).