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Quality & Systems Usability Requirements For Drug Delivery Devices & Systems

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.

US FDA Issues Guidance On Human Factors Studies For Combination Products

Gross, M., Shames, A. (2016). US FDA Issues Guidance On Human Factors Studies For Combination Products. This is the second in a series of articles covering quality system requirements for combination products and borderline products in the US and EU. In February 2016, the US FDA issued three guidance documents which focus on identifying, assessing and mitigating hazards related to how people use medical products that include a medical device.