FDA Guidance on Applying Human Factors and Usability Engineering

United States, July 2, 2014 (Newswire.com) - The webinar will introduce you to the processes covered in that guidance, and how those processes apply to developing medical devices that are safer and meet FDA's latest expectations. This FDA guidance has stepped up expectations for systematic analysis of the hazards associated with the user-device interface. The FDA has stated: "To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used."
In a 2011 study, the FDA identified that predictive risk management process (such as human factors/usability analysis)are weak or missing in many medical device companies. That study emphasized the importance of predictive processes that incorporates user feedback e.g. ISO 14971 risk analysis, FMEA, Human Factors Analysis. FDA has targeted this area for improvement. This webinar will provide an introduction to the processes and requirements presented in "Applying Human Factors and Usability Engineering" and how to use them to developing safer and compliant medical devices.

Why Should you Attend:
Increased Regulatory Focus and Improved Quality - This is a rapidly growingarea that focuses on ensuring that user-related hazards are address early in product development. It requires user related labeling, user device controls/warnings and user device manipulation, are qualified by end user validation.

Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design

Susan Partov, Media Person

About Russell Pizzuto: 

Russell Pizzuto has 40 year of experience in engineering and management with 12 years in medical device design, manufacturing and regulatory compliance. As a Design Engineering, Project Engineer and Director of New Product Development he has developed hundreds of new consumer and industrial products for fortune 500 companies. As Global Director of Engineering for a major medical products manufacturer with teams in USA, Europe, China and Mexico he delivered Class I and Class II medical device projects.

For the last two years he has served as President of PPRE Consulting, specializing in Product, Project and Regulatory Engineering. He holds a Medical Device certificate from the Regulatory Affairs Professionals Society (RAPS), has work on the FDA’s Hospital Bed Safety Work Group and served as an expert witness in Hospital Bed Safety litigation. Mr. Pizzuto has most recently focused on helping clients under FDA legal action, to bring their Design Control and Risk Management Systems into compliance.

About Online Compliance Panel:

Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

For Registration  link http://bit.ly/FDAGuidance_ApplyingHumanFactor