World Conference Calendar

34594 Conferences

FDA Guidance on Applying Human Factors and Usability Engineering

Added by OCPcompliance on 2014-07-25

Conference Dates:

Start Date Start Date: 2014-07-30
Last Date Last Day: 2014-07-30
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2014-07-30

Conference Contact Info:

Contact Person Contact Person: David Jonathan Moses
Email Email:
Address Address: 38868 Salmon Ter, Fremont, CA, 94536, United States
Phone Tel: 15108575896

Conference Description:

Instructor: Russell Pizzuto |

"Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design" was published by the FDA on June 11, 2011. 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.

Objectives of the Presentation:
Processes and Requirements Covered
Device Users, Use Environments and User Interfaces
Analytical Methods for Identifying, Evaluating and Understanding Use-Related Hazards
Identification of Known Problems
Contextual Inquiry
Interviews and Focus Groups
Function and Task Analysis
Heuristic Analysis
Expert Review
Formative Evaluations
Cognitive Walk-Through
Simulated Use Testing
Mitigation and Control of Use-Related Hazards
Design Verification Testing
Human Factors Validation Testing
Simulated Use Validation Testing
Tasks and Use Scenarios
Clinical Validation Testing

Who can Benefit:
Project managers
Quality managers and staff
R & D, Product Development and Sustaining Engineering, managers and staff
Regulatory and Compliance managers and staff
Compliance and Product Development Consultants
Anyone with Product Development, Risk Management, Regulator or Quality Assurance responsibilities

Quick Contact commerce/webinar/~product_id=500426?expD

Toll free: +1-510-857-5896
Email: webinar@onlinecompliancepanel.c om
OnlineCompliancePanel LLC,
38868 Salmon Ter,
Fremont, CA 94536, USA
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