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FDAnews Announces Human Factors and Usability Studies: Understanding and Optimizing Interaction with Medical Devices Webinar, July 16, 2015

Human Factors and Usability Studies:
Understanding and Optimizing Interaction with Medical Devices
**FDAnews Webinar**
July 16, 2015 — 1:30 p.m. – 3:00 p.m. EDT

The FDA works with manufacturers to help ensure the application of human factors engineering to the design of new products as well as to postmarket surveillance of currently marketed products.

Human factors are the things which affect how people interact with medical devices. The FDA will only approve devices which are designed so that it is practically impossible for people to accidentally harm themselves if they use it improperly. As the designer of the device, the burden of proof is on the manufacturer to show that the interface of the device prevents this from happening.

The FDA has replaced the term user error with use error: problems or adverse events caused by faulty interaction between humans and medical devices. FDA documents state that use error is considered to be a device nonconformity because human factors should have been considered during the design phase. From IEC 60601-1-6: “Manufacturers must demonstrate that their device enables users to perform tasks with little or no chance of an error that could cause harm to patients or themselves.”

Hazards related to medical device use should be addressed during device development as part of the risk management process. Potential use-related hazards are best identified and addressed using human factors studies. After use-related hazards are understood, the hazards are eliminated or reduced by modifying the device user interface.

Manufacturers seeking approval for new devices must submit evidence of systematic human factors analysis of use errors and how they will be controlled throughout the product development process.

This webinar will explain the process for conducting human factors studies, integrating it with the device risk analysis and validating the effectiveness of the studies. The various types of human factors studies will be described.

Meet the Presenter:
Edwin Waldbusser has over 22 years of experience in regulated industry. He is certified by Lloyd’s of London as an ISO 9000 Lead Auditor, and is a member of Thompson Reuters’ Expert Witness Network. He has qualified and/or audited over 40 medical device contract manufacturers; recent projects have involved the Mayo Clinic, Johnson & Johnson, Baxter, Canon Life Sciences, Panasonic USA, CareFusion and LifeWatch. He has written dozens of SOPs, holds five patents and has brought a company under a consent decree into compliance.

Who Will Benefit:

  •     Auditors
  •     Compliance Officers
  •     Engineering and Design Control Teams
  •     QA/QC Personnel
  •     R&D Staff
  •     Risk Management Specialists
  •     Validation Specialists
  •     Scientists
  •     Engineers

Conference Details:
Human Factors and Usability Studies:
Understanding and Optimizing Interaction with Medical Devices
**FDAnews Webinar**
July 16, 2015 — 1:30 p.m. – 3:00 p.m. EDT

$287 per site

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic

Read the full story at

Source: PRWeb
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