April 20, 2011 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast Wednesday, 20 April, that will cover the regulatory requirements and testing objectives of Human Factors/Usability Engineering (HFE/UE) in medical device design. Regulators including the US Food and Drug Administration (FDA) require HFE/UE to be applied in the design and evaluation of medical devices. Failure to comply with increasingly stringent HFE/UE requirements has led to recent rejections of medical device application submissions and audit observations during design control inspections. During this webcast, subject matter experts will provide an overview of HFE/UE applied to medical products; explain the regulatory requirements and describe the role of the latest standards, including AAMI HE-75 and IEC 62366; and review usability testing processes.
Who:
- Edmond W. Israelski, PhD, CHFP, director of human factors, Abbott
- Kathi Durdon, MA, CCRP, manager of clinical operations, Welch Allyn
What:
90-minute webcast entitled Human Factors/Usability in Medical Device Design: An Overview of Regulatory Requirements and Testing Objectives
When:
20 April, 12:00–1:30 pm EDT
How to Access:
Members of the working media may request access to this live RAPS webcast by contacting Zachary Brousseau, senior manager, communications, RAPS, at zbrousseau@raps.org or +1 301 770 2920, ext. 245.
About RAPS
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org
