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Human Factors/ Usability Studies Following IEC 62366 and the New FDA Guidance

Faculty :

Industry :

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Course Description:

         One of the first step in redressing the clinical underreporting data gap has already been implemented by the standards community by replacing the term User Error with Use Error. FDA defines use error as An act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user. It takes the onus off the user by providing only the identification of what happened, not why it happened. It is no longer the users fault if the device causes the user to commit an error.

         Usability, and the consequences of how people interact with medical devices, are important in device design and testing, and malpractice and product liability litigation.

Usability and human factors are used by FDA more often for :
  • Including safety alerts
  • Encouragement of certain recalls
  • The process of device clearance and approval

Why should you Attend?

         FDA constantly strives to approve devices which are designed so that it is almost impossible for accidental usage harm to people. Still there is loads of evidence that doctors, nurses and patients make user error while using medical devices that result in patient harm. FDA and other international regulatory agencies identified that manufacturers must pay more attention to human factors at the earliest stages of product design and development, when user input can make a difference.

         Due to clinical under-reporting, the number and nature of close calls is unknown. Undefined close calls make it difficult for product design and development team to analyze and potentially correct the issue. International Electrotechnical Commission (IEC) standards call these under reported close calls Slips, Lapses, and Mistakes and most of these are device-use errors that have the potential to result in serious hazards.

Areas Covered:

In this webinar you will learn
  • The changes to ISO 62366 standard
  • The changes to (2016) FDA Guidance
  • The process of conducting rigorous usability and human factors studies during
  • (1) the product design process (2) integrating it with the device risk analysis & design process & (3) validating the effectiveness of the studies
  • Various types and methods of human factors analysis
  • User error versus use error
  • User profiles
  • Use scenarios
  • Step by step human factors program development
  • Common Mistakes and how to avoid them

Who will benefit?

This webcast will be of a valuable assistance to the below audience.

  • Development Engineers
  • Engineering Management
  • Production Management
  • QA/ QC personnel
  • Software developers

Registration Options

Avail 12 months unlimited access for a single user.

Material shipped within 15 days post webinar completion & get life time access for unlimited participants.


ISO 62366, FDA Guidance, Validation Studies, Human Factors, FDA, Medical Device, Device Validation, Risk and Validation Activities, Sample Size Requirements, Engineers, QA, QC

Speaker Details

Edwin Waldbusser

Edwin Waldbusser

Medical Device Consultant

Ed Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Refund Policy

Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: or call +1-888-222-5917 (Toll Free).