Product Description

In a ***1 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 ****1 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
• Documentation

Country:	USA
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