November 27, 2012
How can risk be mitigated in the product development process? How can human factors professionals from vastly different industries work together to gain insight into their own processes? These are just two of the hard questions that next week’s MDG Forum, Design and Human Factors Keys to Innovative Medical Device Products: Expert Views on Mitigating Risk in the Development Process aims to answer.
Referencing the FDA’s latest human factors guidance document “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” from June, human factors professionals will draw from their own experiences in exploring the FDA’s latest thinking and expectations.
Panel members, including our own Clinical and Regulatory Project Manager, Pam Davol, will describe their approach to tackling human factors related to both physical and digital products, share techniques for identifying anticipated — and unanticipated — use-related hazards, discuss the development and application of strategies to mitigate or control use-related hazards, and review approaches to be able to demonstrate safety and efficacy through human factors validation testing.
For more information and to register for the December 5th event, click here.
NOTE: Registration ends 12/3
About Pam Davol, Clinical & Regulatory Project Manager: Through her understanding and application of the scientific method in combination with her interdisciplinary background, Ximedica’s Pam Davol has exhibited a track-record for successfully guiding translation of medical products through all phases of development and the regulatory clearance/approval process. She has 24 years of experience in scientific research and medicine during which she led and managed the research and development, good manufacturing practices, quality system requirements, human factors usability validation, clinical investigations, and regulatory submissions of numerous drug, biologic, device and combination products.