Human Factors/ Usability following ISO 62366 and new FDA Guidance


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 design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, softw....

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



Webinar Id: LSHCHEW002

Training Options:

Duration: 60 mins

 06/27/2017

 10:00 AM PST | 01:00 PM EST

 Single Attendee: [Only for one participant]

 $179 (Live)                    $304 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

 $363 (Live)                    $488 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

 $726 (Live)                    $945 (Live + Recorded)

 Recorded: [Six month unlimited access]

 $217(Single Attendee)  $599 (Unlimited Attendee)

Refund Policy
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