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Human Factors/ Usability following ISO 62366 and new FDA Guidance
 
 
Edwin Waldbusser

Ed is Keynote Speaker at Compliance key Inc. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes

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Overview
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance.
 
Why should you attend this webinar?
The FDA will only approve devices which are designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term "user error" with "use error". This means that use error is considered by the FDA to be a device nonconformity because human factors should be considered in the design process. The burden is on the device designer to create an "idiot proof" product
 
Areas Covered in the Session:
  • User error versus use error
  • Use related hazards and risk analysis
  • User profiles
  • Use scenarios
  • Step by step human factors program development
  • validation
 
Who can Benefit:
  • Development Engineers
  • Engineering Management
  • Production Management
  • QA/ QC personnel
 
Product Id : LSHCHEW002
Training Options                        Duration: 60 mins
06/27/2017  10:00 AM PST | 01:00 PM EST
Single Attendee:   [Only for one participant]
Price: $165 (Live) Price: $270 (Live + Recorded)
Multiple Attendee:   [For a group of 2 to 5 participants]
Price: $335 (Live) Price: $440 (Live + Recorded)
Corporate Attendee:   [For a group of 6 - 10 Participants]
Price: $670 (Live) Price: $775 (Live + Recorded)
Recorded   [Six month unlimited access]
Price: $193
     Refund Policy
 
Upcoming Webinar of Edwin Waldbusser
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