News and Insights

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

By Chris Gosnell 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).

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. March 29-31, 2016  (3 days)  Chemical Heritage Foundation Conference Center 315 Chestnut Street Philadelphia, PA 19106 Through interactive classroom lectures, discussion of case studies and sharing of experience, this 3-day advanced training is intended to enhance participant understanding of the topics listed below. Human Factors: Building and then optimizing your company’s human factors and usability engineering process and how that can be applied to every development project in order to reduce development delays and improve the chances of first-time success. Understanding the different human factors and usability expectations of the three US FDA centers (CDRH, CDER, and CBER) and EU Notified Bodies. Establishing reasonable expectations with reviewers so that re...

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. June 14-16, 2016  (3 days)  Barbizon Palace, Amsterdam Through interactive classroom lectures, discussion of case studies and sharing of experience, this 3-day advanced training is intended to enhance participant understanding of the topics listed below. Human Factors: Building and then optimizing your company’s human factors and usability engineering process and how that can be applied to every development project in order to reduce development delays and improve the chances of first-time success. Understanding the different human factors and usability expectations of the three US FDA centers (CDRH, CDER, and CBER) and EU Notified Bodies. Establishing reasonable expectations with reviewers so that review meetings and submissions have successful outcomes. Utilizing hum...